2016 Quality Management System Vendor Software Benchmark Report

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*Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns.

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INTRODUCTION


The purpose of this survey was to collect data from companies on enabling technology currently used to

support key areas of their Quality Management System.

Data was collected from the LinkedIn Quality & Regulatory Network group representing over 109,000

professionals worldwide. Over 400 members from multiple industries participated.

Percentages do not reflect data for market size, vendor market share or leadership

position. Data only reflects vendor selections from survey participants.

Listing of all Software Vendors mentioned by participants in this survey can be found in the Appendix. Not all

vendors may be represented in their category. If you are a Vendor that is not currently on our list, we welcome

the chance to have you participate in the 2017 QMS Vendors Benchmark Survey.

Any questions about this Survey can be sent to Nikki Willett, Founder/Owner LinkedIn Quality & Regulatory

Network.

The Quality & Regulatory Network would like to thank our helpers in creating the base report. I would also like

to give special recognition and thanks to my Partners C.M. Schramm and Bob Mehta for their on-going support

and help in getting this report finished. I couldn’t do this without their expertise, dedication and quality control.

Thank you Clare and Bob!

LinkedIn, the LinkedIn logo, the IN logo and InMail are registered trademarks or trademarks of LinkedIn Corporation and its affiliates in

the United States and/or other countries. All other references to company and product names are copyright in their own right.

mailto:[email protected]?subject=2016 QMS Software Vendor Survey

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SPECIAL THANK YOU TO OUR 2016 SPONSORS



A very big thank you to our PlatinumSponsor, Arena Solutions, and all of our sponsors – Gold, Silver and Bronze. Your kind support allows us the resources to research, analyze and finalize the QMS Benchmark Report. An additional thank you goes out to our media sponsors helping us to announce the Survey Launch and Final Report availability. Thanks again!Cognizant MedVantage

Cybermetrics

FormPipe

MasterControl

Motto Systems

Traction Software

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OBSERVATIONS AND COMMENTS FOR 2016

Demographics - Industry

Not surprising that the Life Sciences (Biotech, Medical Device, Pharmaceuticals) industry maintains the leadership position in responding to the Survey as thy are the most vocal in the LinkedIn Quality & Regulatory Network group. However, we are seeing growth in other industries such as Laboratories potentially impacted by Health Care regulations or threat to move control under FDA.

With the growing complexity of global regulatory changes and their impact on Quality, larger companies are trying to improve their visibility across the entire enterprise by consolidating and standardizing on a single QMS platform. More large and boutique consulting firms are now recognizing that Quality and its QMS software are taking a more prominent role in the supply chain with enterprise system implementations. Not quite an ERP implementation complexity, but the paradigm shift from easily managed site “antiquated” systems and paper-based models are causing challenges in enterprise-wide cultural adoption that change and automation are a “good thing.” Greater facilitation and leadership support will be greatly needed to see the change in the Quality Maturity to the next level.

Demographics - Company Size / Revenue

Half of the participants were from small companies with revenues less than 100M. The interest in deciding on keeping paper or starting with automation as they progress to their first product submissions is high on the minds of these companies. Although low in funding for automation, many of these companies are seeing the benefits of starting automation now, such as Document Management, to set the structure of the company before it becomes wild and crazy with barely a breath to stop and consider trying to fit in an electronic system implementation. These small companies are ideal to leverage the technology, sustainability and cost of Cloud-based solutions.

Demographics – Survey Participants

More than 80% of the (blind) participants took this survey for the first time. Some participants may have not taken the survey again has things had not changed from previous years. To be more accurate in our figures, we are looking at ways for prior participants to easily state that the new year hasn’t really changed.


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OBSERVATIONS AND COMMENTS FOR 2016Functional Categories – Vendor Profiles

A plethora of vendors were selected for each of the categories, as seen in the charts. These may be a result of companies having more than one system and therefore doing a multi-selection or the result of the new Cloud-born solutions representing the smaller companies embracing the technology into their overall growth plan. A few of these vendors listed last year are no longer with usshowing us only the strong survive or get acquired.

Some Feedback from Participants Concerning their System of Use:• Licensing costs for companies consolidating into one instance for the enterprise• Companies need to stay on top of the vendor during implementation• Length of time some systems take to get up and running• Global use is hindered by time zone issues• Consolidation, migration and cultural adoption• Workflow process is complex to configure and maintain• Challenge or lack of interfaces to other manufacturing and document management systems• Standard QMS does not work well with contract manufacturers• Need better interface between call center system and complaint handling solution. Vendor does not have good business sense of

different call types.• Need guide for country jurisdiction and regulations of complaints globally• Many solutions not providing OOS especially for lab• Not all QMS systems connect well with GMP Training System• Support outside the client time zone• Validation challenges• Cost is high• User interface is not intuitive• Not impressed with Top IT provider GxP capabilities and understanding business needs


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Most of the comments were focused on the difficulty of implementation, especially global, working with the software vendor and finally costs. Larger companies are maturing and through M&As have the need to consolidate all their systems into a single enterprise instance. With that comes the cost not just from the vendor, but the internal costs spent on having dedicated resources from IT and especially business throughout the entire project. Vendors need guidance and may not understand the terminology of the business. Complexities like data migration, multiple integration, master data and archivingare all things that need to be planned upfront before finding out too late additional requirements and complexities that justpop up.

Some solutions like Calibration and SPC especially at a plant site, although critical to the overall manufacturing process, is not the highest priority in converting to an automated solution and hence many are still using manual processes (including index cards). The interest from quality and manufacturing engineers is high to help reduce work overload, but the progress is slow.Most are satisfied if they move to the functionality contained within their ERP or just tracking solutions provided by QMS software vendors.

Complaint handling and CAPA may be the ones that have more complex process of all the functional areas, but after all a CAPA is a CAPA. However, those organizations that try to replicate their paper-based processes, may just find the things that weren’t working before in a manual process are still not working when automated. This is because companies are trying to automate every detail for every type of workflow around each specific product class, country, and other attributes, or are trying to force-fit functionality into a software solution not built for it. Each approach causes complexity and typically results in a user interface that is not intuitive especially for infrequent users. Customization or lengthy configurations will also make the cost higher for implementation and maintenance. Good rule is 80% out-of-the-box and 20% formatting changes or additional configuration. Lastly, with the changing global regulatory landscape, companies not only need to think of country jurisdiction when a complaint occurs but bring regulatory into the fold of manufacturing release so the right product is released to the right country at the right time.


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8

LIMS and MES still appear to have automation adoption challenges. A lot of companies are using manual processes in the lab or on the shop floor. Although a lot of opportunity for growth, typically there is no clear strategy for automation or integration with other systems. Batch records are still predominantly paper-based, a risk for accuracy and compliance, and you can still find rooms filled with locked cabinets.

Still considered a relatively new idea in some industries, we’ve seen changes recently with PLM. In the past, PLM was owned by Development/Engineering. However, since Quality is across the entire product value chain we are now seeing many organization shift the ownership to Quality resulting in PLM vendors adding more functionality to support product quality lifecycle. Although on the rise, many companies still lack a PLM and try to make up for it by using many different systems – adding to the complexity for their users.

It’s not surprising to hear that Top IT providers implementing quality solutions do not have impressive GxP capabilities nor understand the business. SMEs with a background in GMP, Validation, Quality and how it’s applied with Vendor Software are the ones that can provide guidance to an IT provider during a project implementation. This role is critical to any QMS implementation success. But do not think that all delivery people whether on-shore or off-shore will have this kind of knowledge except for what they hear when on-boarded to the project.


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OBSERVATIONS AND COMMENTS FOR 2016Technology Trends

Last year there were a greater number of participants saying they had no cloud-based solutions within their organization. This year is 50% less. Although Cloud technologies increasingly become mainstream, only 30% of respondents think Cloud is a positive trend for Quality Management Systems. While many organizations embrace Cloud, security and regulatory compliance concerns are a limiting factor to broader adoption. Lack of GAMP and FDA guidelines for SaaS and Cloud-based systems are also a major concern.

Although Cloud and security was mentioned many times, the biggest trends that participants are watching are Mobility and DigitalTransformation

Other Observations – Years Used, Satisfaction, Installation, Implementation

Most participants said they have been using their systems from 1-3 years and only a small portion had something implemented within the last year. As companies may evaluate their software lifecycle from 3-5 years, we might see an uptick in new system acquisitions especially for CAPA, nonconformances and deviations especially on the shop floor and replacing old or adding new document management systems. The uptick in Document Management can be either small companies embracing automation or a plethora of lower cost Cloud solutions being available.

For the most part, even seeing issues and challenges with their system and vendor as part of the survey feedback, participants mostly felt good about their QMS system.

Companies are still trying to everything themselves including implementing QMS systems with some help from the vendor. This approach may be overwhelming to IT and especially to Business and may cause a company to miss out on the benefits of leading practices that both a software vendor and service providers can provide from vast experience with customers. Over run projects, difficulties keeping to schedules is not the fault of internal resources nor vendors, but the lack of having resources dedicating time to a project.

Consideration on external resources may be need to help drive the strategy and roadmap before jumping directly into a large program implementation, especially those that are enterprise-wide or have multiple business units involved.


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NUMBER ONE CHALLENGE

Although cost is always on the top 3 of the list of challenges in implementing a Quality system, the feedback on the number one challenge is cultural adoption. Users comfortable with paper need early training on the benefits of automation for their own job, department and company. In addition, the voice of the company needs to be heard even if implementation will be done in another phase or year. Leaders need to be very supportive and help commit to the long term investment. If culture is not considered as part of planning phase of a new Quality system, there will be greater potentials for failures.


10

IF YOU’RE GOING TO RISE TO

THE CHALLENGE, YOU HAVE TO

BE PREPARED TO CHANGE.

Internal/External Audit

Calibration & Maintenance

CAPA (Corrective & Preventive Actions)

Change Control

Complaints

Document Management

Exceptions (Deviations, Non-conformances)

Environmental Health & Safety (EH&S)

Laboratory Management (LIMS, ELN)

Manufacturing Execution System (MES)

Product Lifecycle Management (PLM)

Statistical Process Control (SPC/PAT)

Supplier Quality

Training

SaaS / Cloud Systems Usage

Challenge in Implementation

Technology Trends Impacting QMS

Resources Needed for On-Going QMS success

Selected Comments from Participants

Appendix I –Selected Vendor Profiles

Appendix II –Vendor List



Sponsored by 12Quality & Regulatory Network LLCCopyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.

DEMOGRAPHICSREPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY

1.1%1.3%

1.1%

1.3%

10.5%1.3%

1.6%

11.1%

2.9%

2.6%

2.1%

1.3%1.6%

12.4%10.3%

1.8%

21.1%

3.4% 11.2%

Academic Research

Aerospace & Defense

Airlines / Aviation

Automotive

Biotechnology

Chemicals

Contract Partner

Consulting

Electrical & Electronic Manufacturing

Food & Beverages

Hospital & Health Care

Information Technology & Services

Laboratory

Life Science Multi-Sector

Medical Device / Diagnostic / Software

Mining, Metals, Paper, Plastics

Pharmaceuticals

Software Vendor for QMS

Other

Bio

Med

Pharma

Life Science

Multi-Sector


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COMPARISON OF INDUSTRY TO 2015



1.1% 1.3% 1.1% 1.3%

10.5%

1.3% 1.6%

11.1%

2.9%2.6%

2.1% 1.3% 1.6%

12.4%10.3%

1.8%

21.1%

3.4%

11.2%

3.5%1.5%

12.4%

1.1%

1.3%

4.3%

3.8% 4.6%

17.6%

35.5%

14.4%

0%

5%

10%

15%

20%

25%

30%

35%

40%

2016 2015



DEMOGRAPHICSREPRESENTATION FROM PARTICIPANTS ABOUT THEIR COMPANY ANNUAL REVENUE

M – Million B - Billion

31.8%

15.8%

8.4%

12.4%

3.7%

3.9%

10.5%

6.6%

2.9% 1.6% 2.4% less than 25M

26-50M

51-100M

101-500M

500-750M

750M-1B

1-5B

5-10B

11-25B

26-50B

Over 50B


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COMPARISON OF ANNUAL REVENUE TO 2015



38.4%

34.8%

8.9%

17.9%

31.8%

15.8%

8.4%

12.4%

3.7% 3.9%

10.5%

6.6%

2.9%1.6%

2.4%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

2015 2016


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DEMOGRAPHICSREPRESENTATION FROM PARTICIPANTS ABOUT THEIR ROLE OR FUNCTION WITHIN THE COMPANY


5.5%5.5%

2.1%

8.7%

4.5%

4.2%

39.2%

3.4%

3.4%0.5%

0.8%

1.6%

0.3%

0.5%0.3%

2.9%

16.6%

Compliance

Engineering

Exec/C-Suite

IT

Management

Manufacturing

Quality Assurance

Quality Control

Regulatory

Risk

R&D

Safety

Security

Supply Chain

Sustainability

Training / HR

Validation


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COMPARISON OF ROLES TO 2015



Note: Some answers were consolidated under one industry while those with only

a single response were allocated to "Other."

8.2%

5.7%8.7%

3.1%

35.3%

15.4%

7.5%

0.1%

2.7%

0.6% 0.7% 0.3%

11.7%5.5%

5.5%

2.1% 8.7%

4.5%4.2%

39.2%

3.4% 3.4%0.5%

0.8%

1.6% 0.3%0.5% 0.3% 2.9%

16.6%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%2015 2016


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DEMOGRAPHICS 2016REPRESENTATION FROM PARTICIPANTS ABOUT THEIR GEOGRAPHICAL REGION


64.7%

1.6%

0.8%

12.6%

0.3%

2.1%

0.8% 17.1% North America

Central America

South America

Europe

Eastern Europe

Africa

Middle East

Asia Pacific


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COMPARISON OF GEOGRAPHICAL

REPRESENTATION TO 2015



62%

14%

20%

2% 2%

13%

64.7%

1.6% 0.8%

12.6%

0.3%

2.1%

0.8%

17.1%

0%

10%

20%

30%

40%

50%

60%

70%

NorthAmerica

CentralAmerica

SouthAmerica

Europe EasternEurope

Africa Middle East Asia Pacific

2015 2016


Please note that each Category has 5 parts:

• Top 2016 Vendors Selected

• Vendor list of “Other” with less than 1%

response

• Time & Satisfaction with the System

• Installation & Implementation of the System

• Comparison to the 2015 Benchmark


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INTERNAL / EXTERNAL AUDIT SYSTEM

21

Note: Some participants may have selected multiple systems if represented within their organizations. Those software vendors with less than

a 1% response are not reflected in the chart but are included in “Other.” Those vendors with no selection are still reflected in the Appendix.



24%

1%

27%

1%1%

10%

4%

1%

7%

1%

3%3% 5%

2%2%

5%

Manual / Microsoft Office

Custom/Internally Developed

ACE (PSC Software)

AutoSHEQ

Cebos

ETQ

GMPPro (MOTTO Systems)

JIRA (Atlassian)

MasterControl

Q-Pulse (Gael)

SAP

SharePoint (Microsoft)

Trackwise (Sparta Systems)

Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER AUDIT VENDORS*

123Compliance (Sparta Systems)

AMPLEXOR

Compliance Control

ComplianceQuest

Documentum Compliance Manager

Ennov Software Solutions

Enovia PLM (Dassault Systemes)

Formpipe.GxP (Formpipe Software AB)

Harrington Group International

HP Quality Center (QC)

IQS, Inc.

MetricStream

NextDocs

Optiva PLM (Infor)

Oracle

QA Systems (QASYS)

QAD

QPR Software PLC

Qualtrax

Qumas (Dassault Systemes)

Rescop

Salesforce

ServiceNow


* Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.


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4%

8%

24%

37%

28%

Awful Poor Average Good Excellent

20.9%

27.2%

13.7%

5.1%14.3%

< 1 year 1-3 years 4-6 years 7-9 years > 10 years

TIME SATISFACTION

TIME & SATISFACTION WITH AUDIT SYSTEM



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INSTALLATION & IMPLEMENTATION OF AUDIT SYSTEM


33.7%

31.6%

2.1%

0.9%0.9%

Totally Internal

Worked with Software Vendor

Used a local service provider

Used boutique service provider

Used top IT service provider

32.8%6.6%

8.7%

5.4%

On-Premise

3rd Party Hosted

Cloud/SaaS Single Tenant

Cloud/SaaS Multiple Tenant

INSTALLATION IMPLEMENTATION


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COMPARISON OF AUDIT TO 2015



23.6%

1.2%

27.4%

1.7% 1.7%

10.1%

3.7%

0.0%1.7%

7.5%

0.9% 0.3%1.4%

3.2% 2.6%

5.5%

2.0% 2.0%

24.6%

7.1%

17.9%

0.0% 0.5%1.5%

0.7%2.1%

1.2%

6.0%

2.3% 1.8% 1.8%

4.6%3.5%

6.9%

0.3%1.0%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0% 2016 2015


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CALIBRATION & MAINTENANCE (CMMS & PM)

26

Note: Some participants may have selected multiple systems if represented within their

organizations. Those software vendors with less than a 1% response are not reflected in the chart

but are included in the list of other Vendors.




21.7%

4.5%

21.3%

1.4%

3.6%4.5%

1.4%

5.4%

1.8%

5.9%

1.4%

1.8%

1.4% 4.5%

1.8%1.4% 5.9%

10.4%



ACE (PSC Software)

AutoSHEQ

Blue Mountain

Calman (SpectraCal)

Cebos

ETQ

GAGEtrak (CyberMetrics Corporation)


IQS, Inc.

JD Edwards (Oracle)

MasterControl

Maximo (IBM)

ProCAL (Prime Technologies)

Q-Pulse (Gael)

SAP

Other


Sponsored by

LIST OF OTHER CALIBRATION & MAINTENANCE

VENDORS*

Access Automation (UCAL)

Ape Software

CERDAAC (Simco Electronics)

Gage Insite (Indysoft Corporation)

GageManager (Altegra)

GAGEpack (PQ Systems)

iBASEt

IBS US

Infor EAMS

LabVantage

Labware

QAD

Quality Systems Toolbox

Rescop

TrackPro

uniPoint Software

Vintara




Sponsored by

TIME & SATISFACTION WITH CALIBRATION &

MAINTENANCE SYSTEM


TIME SATISFACTION

11.5%

23.4%

8.7%4.8%

31.7%

1-3 years 4-6 years 7-9 years Other

3%

13%

29%

32%

23%



Sponsored by

INSTALLATION & IMPLEMENTATION OF

CALIBRATION & MAINTENANCE SYSTEM



31.7%

3.2%

4.8%

2.2%

On-Premise

3rd Party Hosted



37.3%

37.3%

3.1%

0.3%

0.7%

21.4%

Totally InternalWorked with Software VendorUsed a local service providerUsed boutique service providerUsed top IT service providerOther


Sponsored by

COMPARISON OF CALIBRATION &

MAINTENANCE TO 2015



17.0%

3.5%

16.6%

4.6% 4.6% 4.2%3.5% 3.5%

2.8%

1.4% 1.4% 1.4%

14.4%

3.2%

0.9%1.4%

4.5%

0.9%0.2%

4.2%

8.0%

0.0%

1.7%0.9%

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

2016 2015


Sponsored by Quality & Regulatory Network LLCCopyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.

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on

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By

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CAPA (CORRECTIVE & PREVENTIVE ACTIONS)




16.0%2.3%

21.7%

1.0%

13.7%4.3%

1.3%

8.7%

1.0%

1.7%

1.0%

2.0%

2.3%

8.0%

2.3%

3.3%

9.3%



ACE (PSC Software)

AutoSHEQ

ETQ


IQS, Inc.

MasterControl

Pilgrim

Q-Pulse (Gael)


SAP



Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER CAPA VENDORS*

123Compliance

Cebos

ComplianceQuest

Empower PLM (Omnify Software)

Ideagen PLC

JIRA (Atlassian)

MetricStream

Omnex

QPR Software PLC

Qualtrax

Redmine

Rescop

TeamPage (Traction Software)

uniPoint Software




Sponsored by

TIME & SATISFACTION WITH CAPA SYSTEM



TIME SATISFACTION

18.0%

35.3%

12.9%

6.1% 11.2%


4%

8%

23%

35%

31%



Sponsored by

INSTALLATION & IMPLEMENTATION OF CAPA




37.3%

37.3%

3.1%

0.3%

0.7% 21.4%

Totally Internal





37.3%6.4%

8.5%

6.4%

On-Premise

3rd Party Hosted




Sponsored by

COMPARISON OF CAPA SYSTEM TO 2015



14.7%

2.1%

19.9%

0.0%

12.6%

4.0%

0.0%

8.0%

0.0%1.5% 1.8% 2.1%

7.4%

2.1%3.1%

22.0%

7.1%

9.9%

1.1%2.4%

1.3% 1.1%

6.6%

1.1%

1.5% 3.3%

1.5%

11.5%

0.2% 0.7%0%

5%

10%

15%

20%

25%

2016 2015


Sponsored by

CHANGE CONTROL





19%

3%

21%

1.0%1.3%

7%4%

1.0%1.0%

10%

1.0%

1.0%

2%

5%

1.3%2%

18%



ACE (PSC Software)

Agile PLM (Oracle)

AutoSHEQ

ETQ


IQS, Inc.

JIRA (Atlassian)

MasterControl


SAP



Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER CHANGE CONTROL VENDORS*

Arena Solutions

Documentum (EMC)

eMatrix/Matrix One PLM (Dassault Systemes)


ISTM (Remedy)

QAD

Qualtrax

Remedy ARS (BMC)

Rescop




Sponsored by

TIME & SATISFACTION WITH CHANGE CONTROL

SYSTEM



TIME SATISFACTION

16.2%

28.9%

11.6%

6.1%9.7%


4%

9%

26%

34%

27%



Sponsored by

INSTALLATION & IMPLEMENTATION OF CHANGE

CONTROL SYSTEM



35.2%4.2%

8.0%

5.2%

On-Premise

3rd Party Hosted



33.0%

23.1%

1.3%

0.3% 1.0%

Totally Internal






Sponsored by

COMPARISON OF CHANGE CONTROL SYSTEM

TO 2015



19.0%

3.0%

21.0%

1.0%0.3%

7.0%

4.0%

10.0%

0.0%1.0%

2.0%

5.0%

1.3%2.0%

23.6%

7.0%

10.6%

3.0%

1.3% 1.3% 1.3%

7.0%

1.5%3.0% 2.6%

10.0%

0.2% 0.7%

0%

5%

10%

15%

20%

25%2016 2015


Sponsored by

COMPLAINTS - PRODUCT QUALITY




17.2%

5.7%1.1%

23.7%

1.5%

9.2%

4.6%

1.1%

1.9%

6.5%

1.1%

1.1% 3.8%

1.9% 4.6%

1.9%2.3% 10.7%




ACE (PSC Software)

AutoSHEQ

ETQ


IQS, Inc.

JIRA (Atlassian)

MasterControl

Microsoft Dynamics

Pilgrim

Salesforce

SAP


Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER PRODUCT QUALITY

COMPLAINTS VENDORS*

Aris Global

ComplianceQuest

isoTracker (Lenox Hill Ltd.)

NetRegulus (PTC)

Q-Pulse (Ideagen Plc.)


Velocity Software

Windchill Quality Suite (PTC)




Sponsored by

TIME & SATISFACTION WITH PRODUCT QUALITY

COMPLAINTS SYSTEM


TIME SATISFACTION

4%

9%

26%

34%

27%


11.4%

21.6%

8.1%

5.1%

7.0%



Sponsored by

2.2%

6.2%

4.0%

On-Premise

3rd Party Hosted




PRODUCT QUALITY COMPLAINTS SYSTEM



2.8%0.3%1.4%






Sponsored by

COMPARISON OF PRODUCT QUALITY

COMPLAINTS SYSTEM TO 2015



19.0%

3.0%

21.0%

1.0% 0.3%

7.0%

4.0%

10.0%

0.0%1.0%

2.0%

5.0%

1.3% 2.0%

23.6%

7.0%

10.6%

3.0%1.3% 1.3% 1.3%

7.0%

1.5%3.0% 2.6%

10.0%

0.2% 0.7%

0%

5%

10%

15%

20%

25%

2016 2015


Sponsored by

COMPLAINTS - ADVERSE EVENTS




6.2%

24.2%2.8%1.7%

9.0%

9.6%

1.7%

5.1%

1.7%2.2%

11.2%Manual / Microsoft Office


ACE (PSC Software)

Argus (Oracle)

Aris Global

ETQ

MasterControl

Pilgrim


Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER COMPLAINTS - ADVERSE

EVENTS VENDORS*


ComplianceQuest

Safefood 360

Tip Technologies




Sponsored by

TIME & SATISFACTION WITH ADVERSE EVENTS

SYSTEM


TIME SATISFACTION

11.4%

21.6%

8.1%

5.1%

7.0%


2%

10%

28%

33%

27%



Sponsored by



ADVERSE EVENTS SYSTEM


31.0%

1.4%0.4%

2.5%





32.5%4.3%

7.6%

6.5%

On-Premise

3rd Party Hosted




Sponsored by

COMPARISON OF ADVERSE EVENTS TO 2015


51

18.9%

4.7%

18.5%

1.8%

1.3%

6.9%

0.0%

7.3%

1.3%

0.0% 0.0% 0.0%

3.9%

1.3% 1.7%

21.8%

8.7%

10.8%

1.5%

0.2%1.2% 1.4%

5.2%

1.0%2.1%

3.3%2.3%

8.3%

0.2%1.0%

0%

5%

10%

15%

20%

25%

2016 2015



52

Se

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Sp

on

so

red

By

Are you a Vendor that is not listed in this Report? Fill out your Profile for

2017 NOW!

Using a system not listed in this Report? Tell your Vendor!


http/:www.softexpert.com

http://www.softexpert.com/

https://www.surveymonkey.com/r/2017sponsors


Sponsored by

DEVIATIONS AND NON-CONFORMANCES





19.4%

4.0%

23.4%

1.1%1.1%

8.6%4.0%

1.4%

8.6%1.1%

1.1%

2.5%

1.8% 5.8%

1.8%

2.2%12.2%



ACE (PSC Software)

AutoSHEQ

Cebos

ETQ


IQS, Inc.

MasterControl

Pilgrim

Q-Pulse (Gael)

SAP



Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER DEVIATIONS AND NON-

CONFORMANCES VENDORS*

Agile PLM (Oracle)

Arena Solutions

Blue Mountain

CAMA Software

ComplianceQuest


JIRA (Atlassian)

Lotus Notes

Montium

Oracle

QMSrs Ltd


Redmine

Rescop

ServiceNow


uniPoint Software




Sponsored by

TIME & SATISFACTION WITH DEVIATIONS AND

NON-CONFORMANCES SYSTEM



TIME SATISFACTION

16.2%

33.1%

14.3%

4.5% 10.2%


4% 11%

24%

33%

28%



Sponsored by



DEVIATIONS/NON-CONFORMANCES SYSTEM



35.0%4.5%

7.9%

6.0%

On-Premise

3rd Party Hosted



33.8%

1.5%0.4%0.8%

Totally Internal






Sponsored by

COMPARISON OF DEVIATIONS AND NON-

CONFORMANCES TO 2015



17.9%

3.7%

21.6%

1.0%

8.0%

3.7%

1.3%

8.0%

1.0%2.3% 1.7%

5.3%

1.7% 2.0%

23.9%

8.7%

10.7%

1.4% 2.4%1.6%

0.4%

7.1%

1.6%3.4% 1.8%

10.1%

0.2% 0.8%

0%

5%

10%

15%

20%

25%

30%

2016 2015



58

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By

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Sponsored by

DOCUMENT MANAGEMENT




13.0% 2.0%

24.6%

1.3%2.7%

8.0%

1.0%

4.3%

1.3%

15.9%

1.0%

1.0% 5.0%

2.0%4.0% 13.0%



ACE (PSC Software)

Cebos

Documentum (EMC)

ETQ

FirstDoc (CSC)


IQS, Inc.

MasterControl


SAP


Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER DOCUMENT MANAGEMENT

VENDORS*

123Compliance

Agile PLM (Oracle)

Arena Solutions

AutoSHEQ

ComplianceQuest

eDOCS (OpenText)

Empower PLM (Omnify Software)

Formpipe.GxP (Formpipe Software AB)

JIRA (Atlassian)

Liquent

Lotus Notes

Montium

NextDocs

Pilgrim Quality Solutions

Q-Pulse (Gael)

Rescop


TRIM Records Management (HP)

uniPoint Software

Veeva




Sponsored by

TIME & SATISFACTION WITH DOCUMENT

MANAGEMENT


TIME SATISFACTION

22.3%

35.2%

10.6%

5.7% 13.6%


2%

7%

23%

34%

34%



Sponsored by


DOCUMENT MANAGEMENT SYSTEM




17.6%2.3%

4.6%

3.1%

On-Premise

3rd Party Hosted



28.8%

46.2%

1.1% 1.9%1.1%

Totally Internal






Sponsored by

COMPARISON OF DOCUMENT MANAGEMENT

SYSTEM TO 2015



12.7%

2.0%

24.1%

0.3%

1.3% 2.6%

7.8%

4.2%

0.0% 0.0%1.3%

15.6%

0.7% 1.0% 1.0%

4.9%

2.0%

3.9%

18.4%

6.8%

16.6%

2.6%

0.6%

6.0%

1.4% 1.2% 1.4% 1.4%0.2%

12.4%

1.8% 1.2% 2.0%

7.4%

0.0%0.8%

0%

5%

10%

15%

20%

25%

30%2016 2015


Sponsored by

ENVIRONMENTAL HEALTH & SAFETY (EHS)




30.4%

5.4%

34.5%

8.1%

2.7%2.0%

16.9%



ACE (PSC Software)

ETQ

SAP

SharePoint

Other


Sponsored by

LIST OF OTHER ENVIRONMENTAL HEALTH &

SAFETY (EHS) VENDORS*

Blue Mountain

DataPipe (Knorr Associates)

ecoLOGIC Systems

Entropy (BSI)

HAZMIN (Logical Technology)

KMI

MSDSonline

QPR Software PLC

SFS Chemical Safety




Sponsored by

TIME & SATISFACTION WITH ENVIRONMENTAL

HEALTH & SAFETY (EHS) SYSTEM



TIME SATISFACTION

9.2%

18.4%

3.4%

3.1%

7.3%


3%

9%

33%

27%

29%



Sponsored by

17.6%2.3%

4.6%

3.1%

On-Premise

3rd Party Hosted





ENVIRONMENTAL HEALTH & SAFETY (EHS) SYSTEM



24.5%

11.9%

0.4%

0.4%

0.4%

Totally Internal






Sponsored by

COMPARISON OF ENVIRONMENTAL HEALTH &

SAFETY (EHS) TO 2015



20.0%

3.6%

22.7%

5.3%

0.4%1.8% 1.3%

19.8%

5.6%

9.9%

0.6% 0.8% 1.2%0.0%

0%

5%

10%

15%

20%

25%

2016 2015


Sponsored by

LABORATORY MANAGEMENT (LIMS, ELN, ETC.)




24.7%

8.6%

4.3%

4.3%

11.8%6.5%

2.2%

3.2%

5.4%

4.3%

2.2%

22.6%



Agilent

Empower (Waters Corp.)


LabWare (Waters)

Lims1 (Ltech Australia Pty Ltd)

SAP

SQL*LIMS

Star LIMS

Thermo Scientific

Other


Sponsored by

LIST OF OTHER LABORATORY MANAGEMENT

VENDORS*

Apollo LIMS (Common Cents Systems)

Blaze LIMS (Blaze Systems)

Clinsys Group

CORE LIMS (Core Informatics)

Labtronic / LABWORKS (PerkinElmer)

Rescop



* Those software vendors with less than a 1% response are not reflected in the chart but are included in this list of other Vendors.


Sponsored by

TIME & SATISFACTION WITH LABORATORY

MANAGEMENT SYSTEM



TIME SATISFACTION

3.8%

10.4%1.9%

2.7%

6.9%


13%

27%

45%

12%

Poor Average Good Excellent


Sponsored by



LABORATORY MANAGEMENT SYSTEM



17.6%2.3%

4.6%

3.1%

On-Premise

3rd Party Hosted



24.5%

11.9%

0.4%

0.4%

0.4%

Totally Internal






Sponsored by

COMPARISON OF LABORATORY MANAGEMENT

TO 2015



13.7%

4.8%

2.4%

0.6% 0.6%

2.4%

6.5%

0.6%

3.6%

1.2% 1.8%

3.0%2.4%

1.2%

13.6%

4.9%

1.4%0.4% 0.2% 0.2%

1.8%

0.6%

3.4%

1.0%

4.9%

3.8%

2.0% 1.4%

0%

2%

4%

6%

8%

10%

12%

14%

16%

2016 2015


Sponsored by

MANUFACTURING EXECUTION SYSTEM (MES)




18.7%

8.8%

2.2%

1.1%

4.4%

3.3%

2.2%

2.2%

3.3%

2.2%

9.9%

41.8%

Manual / Microsoft Office)


Apriso (Dassault Systemes)

Camstar (Siemens)

Epicor

Infor

Oracle

QAD

Rockwell

SAGE

SAP

Other


Sponsored by

LIST OF OTHER MANUFACTURING EXECUTION

SYSTEM VENDORS*

IBS US

JDA

MAPEX Software

Navision (Microsoft)

NetSuite


Werum Software & Systems

Wonderware (Invensys / Schneider Electric)




Sponsored by

TIME & SATISFACTION WITH MANUFACTURING

EXECUTION SYSTEM



TIME SATISFACTION

2.3%

7.3%

2.7%2.7%

12.0%


3%

13%

44%

37%

4%



Sponsored by



MANUFACTURING EXECUTION SYSTEM



16.6%

1.5%1.9%

0.0%

On-Premise

3rd Party Hosted



11.6%

11.2%

1.2% 0.0% 0.8%

Totally Internal






Sponsored by

COMPARISON OF MANUFACTURING EXECUTION

SYSTEM TO 2015



10.2%

4.8%

1.2%0.6%

2.4%1.8%

1.2% 1.2%1.8%

1.2%

5.4%

0.6%0.0%

9.3%

6.7%

0.2%

1.0%0.4%

1.0%

2.6%

0.6%1.0%

0.2%

8.3%

1.0% 1.0%

0%

2%

4%

6%

8%

10%

12%

2016 2015


Sponsored by

SECTION SPONSORED BY




Sponsored by

PRODUCT LIFECYCLE MANAGEMENT (PLM)




25.9%

9.9%

4.9%3.7%

1.2%1.2%

3.7%13.6%

1.2%

18.5%

8.6%

1.2% 1.2%

4.9%



Agile PLM (Oracle)

Arena PLM

eMatrix/Matrix One (Dassault)


ETQ, Inc.


OnePlace (Eclipse Computing)

PSC Software

SAP

Siemens PLM

Windchill PLM (PTC)

Other


Sponsored by

TIME & SATISFACTION WITH PRODUCT

LIFECYCLE MANAGEMENT SYSTEM



TIME SATISFACTION

4.3%

13.6%

1.2%

6.2%


1%

8%

36%

29%

26%



Sponsored by


PRODUCT LIFECYCLE MANAGEMENT SYSTEM




14.3%

1.6%

3.1%

1.6%

On-Premise

3rd Party Hosted



12.8%11.2%

1.2%

0.0%

0.0%

Totally Internal






Sponsored by

COMPARISON OF PRODUCT LIFECYCLE

MANAGEMENT TO 2015



12.6%

4.8%

2.4%1.8% 1.8%

6.6%

9.0%

4.2%

0.6% 0.6% 0.6% 0.6% 0.6%0.0%

10.6%

5.9%

6.7%

0.4%0.0%

1.4%

0.0%

6.1%

0.6%

0.2% 0.2%

1.4% 1.4% 1.2%

0%

2%

4%

6%

8%

10%

12%

14%2016 2015


Sponsored by

STATISTICAL PROCESS CONTROL (SPC) /

PROCESS ANALYTICAL TECHNOLOGY (PAT)




24.8%

5.3%

0.9%

8.0%

2.7%0.9%

14.2%

26.5%

0.9% 12.4%



Cebos


Infinity QS

ISP Software Solutions

Microsoft Excel*

Minitab

Northwest Analytics (NWA)

PQ Systems

SIMATIC (Siemens)

Synergy (Zontec)

WinSPC (DataNet Quality Systems)

Other

*Due to analytical capabilities in MS Excel, this has been extracted from Manual/MS Office into a specific response.

All


Sponsored by

TIME & SATISFACTION WITH SPC/PAT SYSTEM



TIME SATISFACTION

2.7%

10.5%

7.0%

2.3%

8.2%


11%

9%

32%



Sponsored by

INSTALLATION & IMPLEMENTATION OF SPC/PAT




21.9%

1.6%1.2% 0.4%

On-Premise

3rd Party Hosted



7.8%

0.4%0.4%0.0%

Totally Internal






Sponsored by

COMPARISON OF SPC/PAT TO 2015



13.6%

2.9%

4.4%

1.5%

7.8%

14.6%

0.5% 0.5%

6.7%

3.1%

0.0%

1.4%

3.5%

5.5%

0.8%0.6%

0%

2%

4%

6%

8%

10%

12%

14%

16%

2016 2015


Sponsored by

SUPPLIER QUALITY




26.4%

2.8%

25.9%7.5%

5.7%

1.4%

5.2%

4.2%

2.4% 4.2%

1.4%

2.8%

9.9%



ACE (PSC Software)

ETQ


IQS, Inc.

MasterControl

SAP



Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER SUPPLIER QUALITY VENDORS*

Ariba

AutoSHEQ (Centurion Quality Management)

ComplianceQuest

Documentum (EMC)

Infor

IQRC

Muddy Boots Software

Oracle

Pilgrim Quality Solutions

QAD

Q-Pulse (Gael)




Sponsored by

TIME & SATISFACTION WITH SUPPLIER QUALITY



TIME SATISFACTION

15.2%

27.3%

7.8%

3.5%10.5%


4%

8%

33%

28%

27%



Sponsored by

INSTALLATION & IMPLEMENTATION OF SUPPLIER

QUALITY



28.5%2.7%

6.6%

5.1%

On-Premise

3rd Party Hosted



30.5%25.4%

0.4% 0.8%0.0%

Totally Internal


Used a local service provide




Sponsored by

COMPARISON OF SUPPLIER QUALITY TO 2015



25.5%

2.7%

25.0%

7.3%

5.5%

0.0%1.4%

5.0%

1.1% 1.1% 1.1% 1.1%

4.1%

2.3%

4.1%

1.4%2.7%

28.1%

8.6%

11.5%

1.4% 1.2% 1.0%0.2%

3.9%

0.0%

1.0%

0.4%

1.4%

4.9%

0.2%

3.1%

0.0% 1.0%

0%

5%

10%

15%

20%

25%

30%

2016 2015


Sponsored by

TRAINING/LEARNING MANAGEMENT




14.4%2.7%

25.9%

1.9%1.5%

6.1%4.2%

1.1%2.7%

13.3%

1.5%

1.5%

2.3%

1.5%4.6%

14.8%



ACE (PSC Software)

ComplianceWire (UL Eduneering)

Cornerstone OnDemand

ETQ


IQS, Inc.

IsoTrain (Softek)

MasterControl

Saba


SuccessFactors (SAP)

Verse

ZenQMS

Other


Sponsored by

LIST OF OTHER TRAINING/LEARNING

MANAGEMENT VENDORS*

123Compliance

AutoSHEQ

Cebos

ComplianceQuest

Halogen Software

NextDocs

PeopleSoft (Oracle)

Pilgrim

Plateau (SAP)


Rescop

SumTotal

Taleo (Oracle)


uniPoint Software




Sponsored by

TIME & SATISFACTION WITH

TRAINING/LEARNING MANAGEMENT SYSTEM



TIME SATISFACTION

19.3%

35.0%

11.8%

4.3% 8.3%


6%10%

26%

32%

25%



Sponsored by


TRAINING/LEARNING MANAGEMENT SYSTEM




30.3%

7.5%

9.1%

7.5%

On-Premise

3rd Party Hosted



29.1%

38.6%

1.6%

1.2%0.8%

Totally Internal






Sponsored by

INTEGRATION OF TRAINING/LMS WITH QUALITY

OR DOCUMENT MANAGEMENT SYSTEM



0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0%

Other

Manually extract data from our Quality or DocumentManagement System and enter it again into the

Training/LMS System

Quality or Document Management System iselectronically integrated with our Training/LMS

System

Training Compliance is part of the Quality orDocument Management System functionality

2.4%

11.8%

20.1%

28.3%


Sponsored by

COMPARISON OF TRAINING/LEARNING TO 2015



14.2%

2.6%

25.4%

1.9% 1.5%

6.0%

4.1%

1.1%

2.6%

13.1%

0.4% 0.7%0.0%

1.5% 1.5%2.2%

0.4%1.5%

4.5%

20.7%

10.4%

12.4%

3.5%

0.6%1.2%

0.2% 0.2%

1.7%

8.7%

1.0% 1.9% 1.5% 1.0%0.2%

2.1%

1.0%0.4% 0.8%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

2016 2015


Sponsored by

SAAS / CLOUD BASED SYSTEMS



What percent of your systems are currently cloud based (or SaaS) or planned to be

within the next year?

14.1%

6.4%

7.6%

6.8%

8.8%

5.2%Less than 10%

Between 11-25%

Between 26-50%

Between 51-75%

Between 76-99%

100% are Cloud based


Sponsored by

COMPARISON OF CLOUD (SAAS) SYSTEMS TO

2015


100

9.2%

14.1%

6.4%

7.6%6.8%

8.8%

5.2%

21.8%

14.0%

7.8%

5.1%

7.4% 7.6%8.5%

0%

5%

10%

15%

20%

25%

2016 2015


Sponsored by

SOME SELECTED THOUGHTS TO THE TREND OF

QMS SOFTWARE MOVING TO THE CLOUD“Easy access, security concerns, private cloud preferred”

“Some people are stuck against it. If you pick your partners correctly, it can be such a positive change” “Uptime statistics are interesting, but more important is how often they update the software, do they have an organized/compliant process to do so and do they have a help desk that answers questions in minutes or hours”

“Great option for small companies, but the costs really add up”

“Only concern is ability to access tables to help define custom queries”

“The speed on interaction with application”

“Managing change control risk is a challenge”

“Takes the burden of data backup systems away and makes life easier for IT”

“I prefer this movement provided that the vendor has a firm grasp on software compliance needs”

“From a quality perspective I do not mind where a service is hosted so long as it can be qualified”

“Cloud based system qualification is new and complex. GAMP or FDA do not have very specific guidelines for cloud based software as yet”

“Makes a lot of sense in terms of accessibility and hardware costs. Customer service is very important to the system running effectively”

“Cloud only means another companies servers. Security is still an issue, as is encryption”

“For our company, cloud is the only way to go. We have limited IT resources. We also want all users to be able to use the system at the same time. Evaluating potential additional usage of cloud computing but moving cautiously”

“Current management is opposed to it”

“It is an excellent concept that works!”

“Risks involved in security of intellectual property are a big concern”

“Security restriction and risk is high for our data types”


101


Sponsored by

BIGGEST CHALLENGE IN IMPLEMENTING QMS



2.0%

2.4%

2.4%

4.0%

5.6%

8.0%

9.2%

9.2%

9.6%

11.2%

12.0%

14.5%

14.9%

18.1%

18.9%

21.7%

0.0% 5.0% 10.0% 15.0% 20.0% 25.0%

Difficulty in rolling out to many locations world-wide

Did not define lean process before automating

Data Management (master, transactional, archived)

Governance and Change Control

Customize too much instead of utilizing out of the box functionality

Integration with company's internal systems

Difficult to configure

Lack of focus from the company (not a priority)

Lack of IT support or IT resource availability during implementation

Lack of business resource availability during implementation

Validation

Requirements harmonization across all Business Units

Cost of implementation

Finding the right Vendor

Cost of licenses / subscription

Cultural adoption (i.e., not user-friendly, manual to electronic, legacy to newsystem, individual vs. harmonized requirements)

What else?

• Acceptance

• Data migration

• Upgrades cause more issues

• Working with systems vendor

preferred supplier

• Security and encryption

• Lack of keeping up with latest versions

• Duration

• Training and support for remote users

• Company politics


Sponsored by

BIGGEST TECHNOLOGY TREND IMPACTING QMS



0% 2% 4% 6% 8% 10% 12% 14% 16% 18%

3D Printing

Internet of Things (IoT)

Intelligent Automation / Smart Machines

Other

Information of Everything

Big Data Analytics

Digital Transformation

Mobility

What else?

• Cloud

• Electronic batch records

• Serialization of pharma products

• Electronic archiving

• Security


Sponsored by

RESOURCE SKILLS NEEDED FOR QMS SYSTEMS FUTURE SUCCESS



With the change of baby-boomers leaving prominent Quality jobs and Millenials coming on-board eager to drive to a new standard, some skills need to be kept at a premium level. Although some of baby-boomers still need better computer skills, this won’t be a problem for Millenials growing up in the age of computers, tablets, smart phones and the internet. Some of the skills needed is not a surprise as these exist today: business process/products and regulatory requirements for Quality, Lean Six Sigma to keep operations efficient without additional cost. But most of all are resources that can be change agents and cultural adoption leaders to help the organization adopt and embrace the new technologies that are affecting Quality now and in the future.

Good trainers who know how to train will be needed to be coupled with business SMEs making sure that the investment in rolling out of new system is being understood and used properly. With new technology, companies will need resources who are critical thinkers and have the ability to correctly recognize, prioritize and control risk. Lastly, with all the technology changes, IT needs a closer relationship with quality / business by having the technical know-how but with business acumen.

• Business Process Engineering

• Training, Certified Trainers and Communication

• Data Management

• Computer Literacy

• Lean Six Sigma

• World-wide regulatory knowledge in manufacturing, supply and post-market surveillance

• System Admin skills beyond one person

• Change Agents, Cultural Adoption Leaders

• Risk Assessment and Impact

• Technical Know-How with Business Acumen

• Compliance Literacy

• Business Analysts with Critical Thinking to Recognize, Prioritize and Control Risk

• Validation

• Facilitation across IT and business and across various business units

• Dedicated team for implementations and updates

• Facilitate standardization across entire enterprise


Sponsored by

SELECTED PARTICIPANT’S COMMENTS IN GENERAL

“Much needed in our world of metrics”

“Have external auditors use ONE system”

“Managing the validation and qualification aspect of the implementation is key”

“The cultural change going from a paper-based to an electronic QMS is the toughest part of implementation”

“FDA is slow to adopt new technologies”

“Once working properly, they have saved us so much time now”

“Continuous usage gives us long term benefits to the company”

“Electronic version should be mandatory”

“Always lean before you automate, begin with the end in mind - define what do you want delivered from the system (reports, metrics, etc.)”

“Real time data is more and more the trend”

“Provide comprehensive training to everyone”

“Need a standardized approach to validation within industry”




Sponsored by

RECOMMENDATIONS FOR 2017 SURVEY

• Risk Management (new)

• Electronic Batch / DHR Records (new)

• Add Customer Service related question(s) to each category

• Validation (new) and add related questions to each category

• Add Mobility related questions to each category

• Which regulations have the most impact to QMS software*

• Add Security and privacy of data related questions to each category

• IoT*

If you have other ideas for next year’s survey, please take our very quick

Survey on Ideas Now! Thanks.


106

* Will take this under consideration but difficult when going across multiple industries or complex ideas.




107

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Arena Solutions989 E. Hillsdale Blvd, Suite 250

Foster City, CA 94404 USA

Arena invented cloud PLM. Its holistic suite of PLM, supply chain and QMS

solutions enables innovative OEMs with complex electronics to manage their

BOMs, facilitate engineering change orders and speed prototyping to improve

margins and collapse time to market. Arena has been ranked a Top 10 PLM

provider and won the coveted Design News Golden Mousetrap Award in 2016.

Contact: Umesh Malhotra

E-Mail: [email protected]

Phone: +1 877 937 1433

Website: www.arenasolutions.com

Facts:

Number of employees: 51-200

Years in Business, Since: 2000

Annual Revenue: Privately Held

Geographic Regions: All

Primary Industries: Automotive, Biotechnology, Computer Hardware, Software,

Networking, Consumer Electronics, Goods, Services, Electrical & Electronic

Manufacturing, Industrial Automation, Machinery, Medical Device, Oil, Gas,

Renewables & Energy, Pharmaceuticals, Plastics, Railroad Manufacturing,

Semiconductors, Telecommunications, Transportation/Trucking/Railroad

Solutions Offered: Adverse Events, Audit Management (Internal/External),

Calibration & Maintenance, Management, CAPA Management, Change

Control Management, Complaints (Product Quality, Technical), Document

Management, EHS (Environmental, Health & Safety) Management,

Exception Management (deviations, nonconformances), Laboratory

Management, PLM, SPC/PAT, Supplier Quality Management, Training

Management

Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES

License Type: Cloud/SaaS Multi-Tenant

Cognizant MedVantage6330 South 3000 East, Suite 200

Salt Lake City, Utah 84121

MedVantage from Cognizant, is a cloud-based solution for Medical Device

Enterprise- built on Force.com and Service Cloud Platform that helps Medical

device Industry for seamless Product Recall/Repair Management Process and

ensures regulatory compliance (GxP, CAPA, FDA 3500A Med Watch, 21 CFR

820, 821 and Part 803) and Post installation field services management.

Contact: GowriShankar Vembu


Phone: +1 408 306 7130

Website: www.cognizant.com/medvantageercontrol.com

Facts:

Number of employees: 5000+


Annual Revenue: 1B+

Geographic Regions: Asia Pac, Europe, Middle East, North America

Primary Industries: Medical Device

Solutions Offered: Adverse Events, CAPA, Complaints, Deviations and

Nonconformances, Supplier Quality


License Type: Cloud Multi-tenant Subscription



Sponsored by

EtQ, Inc.399 Conklin Street, Suite 208

Farmingdale, NY 11735 USA

EtQ's flexible platform has been the foundation for automating critical compliance

solutions for over 20 years. Whether you are looking for an enterprise solution,

mid-market solution, or you're an individual contributor, EtQ truly has a solution

for every company in the world. The result is a set of solutions for all market types

residing on a common, proven and strong compliance platform technology. This

means that regardless of size, scope, or investment, EtQ has a product for you.

Our product family consists of EtQ Reliance for Enterprise, Verse Solutions for

SMB, and traqpath - our free compliance event and CAPA tracking app for mobile

and Web.

Contact: Timothy Lozier


Phone: +1 516 293 0949

Website: www.etq.com

Facts:





Primary Industries: All

Solutions Offered: Adverse Events, Audit, Calibration & Maintenance, CAPA,

Change Control, Complaints (Product Quality, Technical), Deviations and

Nonconformances, Document Management, EHS, PLM, Supplier Quality,

Training

Certifications: ISO 9001, ISO 27001


License Type: On-Premise, Cloud Single-tenant subscription, Cloud Multi-tenant

Subscription


CyberMetrics - Bronze1523 W. Whispering Wind Drive, Suite 100

Phoenix, AZ 85085

CyberMetrics Corporation delivers world-class, auditor-recommended software

solutions for calibration management and maintenance management that are

flexible, scalable and easy to implement, manage and use. Over 12,000

facilities worldwide choose our software solutions to assure standards

compliance, maximize efficiency and reduce costs.

Contact: Shana Jordan


Phone: 480-371-2333

Website: http://www.cybermetrics.com

Facts:





Primary Industries: Automotive, Biotechnology, Chemicals, Consumer

Electronics, Goods, Services, Cosmetics, Defense & Space/Military,

Electrical & Electronic Manufacturing, Food & Beverages, Gambling &

Casinos, Glass, Ceramics, Plastics& Concrete, Hospital & Health Care,

Industrial Automation, Machinery, Medical Device, Mining & Metals, Oil,

Gas, Renewables & Energy, Packaging & Containers, Paper & Forest

Products, Pharmaceuticals, Transportation

Solutions Offered: Calibration & Maintenance, Document Management,

Supplier Quality Management, Training

Certifications: ISO 9001, ISO 13485, ISO/TS 16949, ISO/IEC 17025, AS 9100



Subscription, 3rd Party Hosted License

http://www.etq.com/



Formpipe Life Science13 Poplars Court

Lenton Lane

Nottingham N G7 2RR UK

The Formpipe Life Science division simplifies complex process and technology

environments to deliver customers’ quality and compliance goals within the relevant

regulatory framework(s). This is achieved through a combination of Consultancy to ‘Get

Compliant’, and Products and Consultancy to ‘Stay Compliant.’ Both are delivered by

experts from the sector. A suite of products addresses the compliance and quality needs of

Life Science organisations, all of which are designed to be easy to use, increase efficiency

and reduce costs across businesses with 50-25,000 users. All Life Science products are

managed using a bespoke internal Quality Management System and are supported and

maintained by a dedicated global team. The company's software helps improve efficiency,

cut costs and reduce risk exposure.

Contact: Keith Williams

Email: [email protected]

Phone: +44 115 924 8475

Website: www.formpipe.com/lifescience

Facts:



Annual Revenue: 1-25M

Geographic Regions: North America, Europe, Asia Pac

Primary Industries: Hospital & Health Care, Information Technology & Services,

Medical Device, Pharmaceuticals, Cosmetics, Chemicals, Biotechnology

Solutions Offered: Training, Supplier Quality Management, Manufacturing

Execution (MES), Laboratory Management (LIMS, LES), Deviations and

nonconformances, Document Management, Change Control, CAPA, Audit

Are you FDA 21 CFR Part 11/ EU DIR Compliant? Yes

License Type: On-Premise (in-house), Cloud (single tenant) Subscription, Cloud

(multi-tenant) Subscription

MasterControl6330 South 3000 East, Suite 200

Salt Lake City, Utah 84121

MasterControl Inc. is a committed team of quality, regulatory and software

experts who work to empower regulated companies to get their products to

market faster. MasterControl's quality management software solutions reduce

overall costs, increase efficiency and accelerate compliance, creating a

significant competitive advantage for customers. MasterControl's complete

quality management solution is designed for easy implementation, validation

and use, continually improving on the promise of Compliance Accelerated.

Contact: Matt Lowe


Phone: 801-942-4000

Website: www.mastercontrol.com

Facts:





Primary Industries: Automotive, Biotechnology, Chemicals, Consumer

Electronics, Goods, Services, Electrical & Electronic Manufacturing, Food

& Beverages, Hospital & Health Care, Logistics, Warehouse & Supply

Chain, Medical Device, Oil/Gas/Renewables & Energy, Pharmaceuticals

Solutions Offered: Adverse Events, Audit, Calibration & Maintenance, CAPA,

Change Control, Complaints, Document Management, EHS, Deviations

and Nonconformances, Supplier Quality, Training

Certifications: ISO 9001


License Type: On-Premise, Cloud Multi-tenant Subscription

http://www.formpipe.com/lifescience


Sponsored by

Motto Systems PVT LTD - BronzeSAMRIDHI VASYAM, JAI HIND COLONY, MADHAPUR

HYDERABAD, TELENGANA 500081 INDIA

Motto Systems’ is an organization that has made pioneering strides in providing

top-class enterprise quality management solutions (EQMS) to Life Sciences’

companies. GMPPro is a end to end quality compliance tool. Driven by innovation

and backed by a qualified team of GMP domain and IT experts. We offer complete

Warehouse, Production, QA, QC & Maintenance modules.

Contact: K RAJGOPA


Phone: +9553444478

Website: www.MottoSys.Com

Facts:



Annual Revenue: 1-25M

Geographic Regions: Asia Pac, Europe, Latin America, Middle East, North

America

Primary Industries: Chemicals, Food & Beverages, Packaging & Containers,

Pharmaceuticals

Solutions Offered: Audit, Calibration & Maintenance, CAPA, Change Control,

Complaints, Document Management, Deviations and Nonconformances,

Laboratory Management (LIMS, LES), Product Lifecycle (PLM), Supplier

Quality Management

Certifications: ISO 9001, ISO 27001


License Type: On-Premise, Cloud Single-tenant subscription


Qualio156 2nd St.

San Francisco, CA 94105 USA

Qualio helps life-saving technologies get to market faster through making Quality

a competitive advantage. A simple dashboard makes it easy to manage all the

daily activities for quality teams. Real-time reporting puts you in control so you can

be audit ready at all times, and built-in QA/RA best practices makes it easy to

build, maintain and scale your quality program. With customers all over the word

from early stage medical devices to public biotechnology organizations, Qualio is a

perfect partner to help your company scale. And with offices in California, Ireland

and Poland – no matter where you are we’ve got you covered.

Contact USA: Colin Moore

Contact Ireland: Damien Barry


Phone: +1 855 203 2010 USA

Phone: +353 1 697 1522 Ireland

Website: www.qualio.com

Facts:




Geographic Regions: Asia Pac, Europe, North America

Primary Industries: Biotechnology, Medical Device, Pharmaceuticals

Solutions Offered: CAPA, Change Control, Complaints (Product Quality, Technical),

Deviations and Nonconformances, Document Management, Training



http://www.qualio.com/



SoftExpert Software201 South Biscayne Blvd. Suite, 1200

Miami/FL USA

SoftExpert is a market leader in software and services for enterprise-wide

business process improvement and compliance management, providing the

most comprehensive application suite to empower organizations to increase

business performance at all levels and to maximize industry-mandated

compliance and corporate governance programs. Along with its extensive

network of international resellers, SoftExpert also provides hosting,

implementation, post-sales support and validation services to ensure that

customers realize the maximum value from their investments.


Phone: 1-646-504-7910

Website: www.softexpert.com

Facts:





Primary Industries: All

Solutions Offered: Audit, Calibration & Maintenance, CAPA, Change Control,

Complaints (Product Quality, Technical), Deviations and

Nonconformances, Document Management, EHS, Laboratory

Management, PLM, SPC/PAT, Supplier Quality, Training

Certifications: ISO 9001, ISO 13485, ISO 14000, ISO 27001



Subscription, 3rd Party Hosted License

Traction Software245 Waterman St., Suite 504

Providence, RI 02906

Traction TeamPage is collaboration software geared towards addressing a

spectrum of ISO related use cases ranging from documentation and management

team meetings/reporting to tracking quality issues and executing on improvement

projects.

Contact: Jordan Frank


Phone: 1-401-487-2268

Website: www.tractionsoftware.com

Facts:




Geographic Regions: Africa, Asia Pac, Europe, North America

Primary Industries: Automotive, Banking, Biotechnology, Chemicals, Computer

Hardware/Software/Networking, Construction, Consumer Electronics/

Goods/Services, Defense & Space/Military, Electrical & Electronic

Manufacturing, Environmental/Facilities Services, Financial Services, Food

& Beverages, Hospital & Health Care, Industrial Automation, Information

Technology & Services, Logistics/Warehouse & Supply Chain, Medical

Device, Mining & Metals, Oil/Gas/Renewables & Energy, Pharmaceuticals,

Semiconductors, Wholesale

Solutions Offered: Adverse Events, Calibration & Maintenance, CAPA, Change

Control, Complaints, Document Management, Deviations and

Nonconformances, Training


License Type: On-Premise, Cloud Single-tenant subscription






Want to be a sponsor for the

2017 QMS Vendor Software

Benchmark Report?

ZenQMS128 Front Street

Conshohocken, PA 18925 USA

ZenQMS develops amazing quality management software for the whole

enterprise. Our cloud-based platform, which includes modules for Document

Management, Issue/CAPA, Training, Audits & Supplier Management, offers

companies a tremendous opportunity to improve quality compliance and save

money.

Contact: Jeff Thomas


Phone: +1 888 280 1433

Website: www.ZenQMS.com

Facts:




Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,

North America

Primary Industries: Biotechnology, Chemicals, Cosmetics, Food & Beverage,

Hospital & Healthcare, Medical Device, Pharmaceuticals

Solutions Offered: CAPA, Change Control, Complaints (Product Quality, Technical),

Document Management, Training







Sponsored by 116

Audit Calibration CAPAChange Control Complaints

Adverse Events

Document Mgmt EHS

Deviations / NCs LIMS MES PLM

SPC / PAT

Supplier Quality Training

123Compliance • • • • • • •4Sight (GE) •

A2Z Manager (Reetec) •ABB LIMS •Accelerys (Dassault Systemes) •Access Automation •ACE (PSC Software) • • • • • • • • • • • •

ActiveQ (Open Mind Solutions) • • • • •Affytrac (Affygility Solutions) •

Adaptive BMS • •Aegis Solutions • •Agilent •

Agile PLM (Oracle) • • • • • •Aleph Tav Technologies • • • • •

Ambrit •AMPLEXOR • • • • • • • • • •

Ape Software •Apollo LIMS (Common Cents Systems) •Apriso (Dassault Systemes) •

Aras Corp • • • •Arena Solutions • • • • • •

Argus (Oracle) • •Ariba •

Aris Global • • •ASI DataMyte •ASKEHS Engineering •

AspenTech •AssessNet •

AssetSmart •Assure (SHE Software) •AssurX • • • • • • • • •Audit Utopia •


http://123compliance.com/

https://www.gemeasurement.com/test-calibration/software/4sight-calibration-and-maintenance-software

http://reetec.com/products/a2z-manager.html

http://www.abb.com/industries/db0003db002806/c12571f4003208d6c1256f890052f24d.aspx

http://accelrys.com/

http://www.aaplweb.com/

http://www.pscsoftware.com/software/ACE/overview

http://open-mind-solutions.com/index.html

http://affytrac.com/

https://adaptivebms.com/

http://www.aiscorp.com/en/

http://www.agilent.com/home

http://www.oracle.com/us/products/applications/agile/overview/index.html

http://alephtavtech.com/

http://www.ambrit.com/index.html

http://www.amplexor.com/corporate/en/industries/life-sciences.html

http://www.apesoftware.com/

http://www.apollolims.com/

http://www.apriso.com/

http://www.aras.com/

http://www.arenasolutions.com/

http://www.oracle.com/us/products/applications/health-sciences/safety/argus-safety/index.html

http://www.ariba.com/

https://arisglobal.com/

http://www.en.asidatamyte.com/

http://www.ask-ehs.com/

https://www.aspentech.com/

http://www.assessnet.co.uk/

http://www.assetsmart.com/

http://www.shesoftware.com/

http://www.assurx.com/

http://www.pscsoftware.com/


Sponsored by 117


Adverse Events

Document Mgmt EHS


SPC / PAT


Audit Weaver • • •Autodesk PLM • •AutoSHEQ • • • • • • • • • •AX for Pharma •BioTrax QMS • • •Blaze LIMS (Blaze Systems) •BLISS LIMS (Baytek International) •BPLM Solutions GMBH •Breeze Software •Bright Interactive •Blue Mountain • • •Caliber Series (Dhruthi Technologies) •Caliso •Calspex (Vantek Software) •CalTrak (Transcat) •CAMA Software LLC • • • • • • • •CAMO Software AS •Camstar (Siemens) • •CAP Software • • •CAQ AG • • • • •Cebos • • • • • • •CERDAC (Simco Electronics) •ChartHouse Data Management •CIMx Software •Cincom •Cintellate (SAI Global) •CIQA • • • • • • • • •CIS Software • • • •Civerex Systems Inc. •Claromentis •Clinsys Group •Clix / Learning Suite (IMC) •CloudSDS •


http://www.auditweaver.com/

http://www.autodeskplm360.com/

http://www.autosheq.com/

http://www.axforpharma.com/

http://www.ec2software.com/pet-quality-management-system/biotrax-qms.aspx

http://www.blazesystems.com/

http://www.baytekinternational.com/

http://wp.bplm.de/english/#start

http://breeze-software.com/

http://www.bright-interactive.com/

https://www.coolblue.com/

http://www.indiamart.com/dhruthi-technologies/software-packages.html

http://www.calisouk.com/

http://www.deterco.com/products/vantek/calspex.htm

http://www.transcat.com/calibration-services/quality/calibration-management/

http://camasoftware.com/

http://www.camo.com/

http://camstar.industrysoftware.automation.siemens.com/en/

http://www.capretail.com/

http://www.caq.de/en/

http://www.cebos.com/

http://www.simco.com/management_solutions/cerdaac_product_suite/introducing-cerdaac-4/

http://www.charthouseusa.com/products/software

http://www.cimx.com/

http://www.cincom.com/

http://cintellate.saiglobal.com/

http://www.ciqa.net/

http://cissoftware.com/

http://civerex.com/

https://www.claromentis.com/learning-platform/

http://www.clinisysgroup.com/

https://www.im-c.com/en/learning-technologies/learning-management

https://cloudsds.com/about


Sponsored by 118


Adverse Events

Document Mgmt EHS


SPC / PAT


CloudQMS (Cambio Services LLC) • • • • • • • •CMO Software •CMX (Beamex) •Cognizant MedVantage • • • • •COMPASS (Process Data Control) •Complaints Pro (Coretec Solutions) •Compli •Compliance 360 (SAI Global) • • • •Compliance Control • • • • • • • •ComplianceQuest • • • • • • • •ComplianceWire (UL Eduneering) •CompuCal Calibration Solutions •CORE LIMS (Core Informatics) •Cornerstone OnDemand •CPRO 2000 Plus (BDR Systems) •Critical Manufacturing •CSC LIMS •Csols Ltd •Cyanic Automation •CyberMetrics • • • •DataLyzer • •DataPipe (Knorr Associates) •Dimensional Control Systems •Dexma •DocSpace (Harcourt Consulting Inc) •Documentum (EMC) • • • • • •DocuShare (Xerox) •Dokeos •DoneSafe •DRM (Donor Dialog) •e3 Solutions •Ease Inc. • • • • • • • • • • •EasyCal (Time Electronics) •


http://cloudqms.com/

https://cmo-software.com/

http://www.beamex.com/software/calibration-software/

https://www.cognizant.com/medvantage

http://www.pdccorp.com/fl/index.php

http://www.coretec.com.au/complaintspro

http://www.compli.com/

http://www.compliance360.com/

http://www.compliance-control.com/

http://www.compliancequest.com/

http://www.uleduneering.com/

http://www.compucalcalibrations.com/

http://www.coreinformatics.com/

http://www.cornerstoneondemand.com/

http://www.thesoftwarenetwork.com/Software-Vendors/BDR-Systems_-Inc_/

http://criticalmanufacturing.com/en/homepage

http://www.csc.com/health_services/offerings/99982/106597-laboratory_information_management_system_lims

http://www.csols.com/wordpress/

http://www.cyanicautomation.com/about/

http://www.cybermetrics.com/en/index.html

http://www.datalyzer.com/

http://knorrassociates.com/

http://www.3dcs.com/

http://dexma-plm.com/en/

http://harcourtconsulting.com/

http://www.emc.com/domains/documentum/index.htm

http://docushare.xerox.com/

http://www.dokeos.com/

http://donesafe.com/

http://www.donordialogue.com/products_drm_touch.html

http://e3solutionsinc.com/home/

https://www.easeinc.com/

http://www.timeelectronics.com/calibration-software/


Sponsored by 119


Adverse Events

Document Mgmt EHS


SPC / PAT


Ecocion •EcoIntense •ecoLOGIC Systems • •eCompliance Management Solutions • • •eDOCS (OpenText) • •EHASoft •EHS Data Limited •EHS Insight (StarTex Software) •eMatrix/Matrix One PLM (Dassault Systems) • • • • •Emerson Process Management MES •EMEX •Empower (Waters Corp.) •Empower PLM (Omnify Software) • • • • • • •EMSolution (Solution Foundry) •Enablon •Ennov Software • • • •Enovia PLM (Dassault Systemes) • • • • •Ensur (Docxellent) • • • • • •Entropy (BSI) • • • • • • • • •Enviance •Epicor • • •EPIQ Technologies, Inc. •Epiware (Epiware Document Management Software) • •ePowerCenter (Astute Solutions) •ERA Environmental Management Solutions •Ethics Point (NAVEX Global) •ETQ • • • • • • • • • • • •eTracker •eTraininfo (CIMCON Software) •Eusoft Srl •Everest (Lynk Software) •


http://ecocion.com/main.html

http://www.ecointense.de/

http://www.ecologicsystems.com/

http://www.ecompliance.com/

http://www.opentext.com/

http://www.ehasoft.com/

http://ehsdata.com/

http://www.ehsinsight.com/

http://www.3ds.com/products-services/enovia

http://www2.emersonprocess.com/en-US/Pages/Home.aspx

http://emex.com/

http://www.waters.com/waters/en_US/Empower-3-Chromatography-Data-Software/nav.htm?cid=513188&locale=en_US

http://www.omnifysoft.com/

http://www.solutionfoundry.com/offerings/software.aspx

enablon.com/

http://en.ennov.com/

http://www.3ds.com/products-services/enovia

http://www.docxellent.com/

http://www.bsi-entropy.com/

http://www.enviance.com/index.aspx

http://www.epicor.com/

http://www.epiqtech.com/

http://www.epiware.com/

http://www.astutesolutions.com/

http://www.era-environmental.com/

http://www.navexglobal.com/products/case-management

http://www.etq.com/

http://trackcustomercomplaints.com/

http://www.cimconsolutions.com/eTraininfo-21-CFR-Part-11-Compliance.asp

http://www.eusoft.it/

http://www.lynksoftware.com/


Sponsored by 120


Adverse Events

Document Mgmt EHS


SPC / PAT


Eyelit, Inc •Factory (Aptean) •Fast Track (Aust) Pty LTD. • • • • • • • • •Field iD (Master Lock) • •FileNet (IBM) •FirstDoc (CSC) •FlexMMS (CGA Software) •FlinkISO open source (Techmentis) • • • • • •Formpipe.GxP (Formpipe Software AB) • • • • • • • • •Fourth Shift (Infor) •Fusion Systems •GageControl (Quality Software Concepts) •Gage Insite (Indysoft Corporation) •GageList (Expresso Moon) •GageManager (Altegra) •GAGEpack (PQ Systems) •GAGEtrak/SUPPLIERtrak (CyberMetrics Corporation) • •GMPPro (MOTTO Systems) • • • • • • • • • • • •Grand Avenue Software • • • • • • • • •Greenlight.Guru • • • • • • • • •GSQA (EMNS Inc.) • •Halogen Software •Hamsagars •Harrington Group International • • • • • •HAZMIN (Logical Technology) •HealthStream •HighJump Software •Honeywell Process Solutions •HP Quality Center • • • • •i-Sight (Customer Expressions) •iBASEt • • • • •IDBS ELN •Ideagen PLC • • • • •


http://www.eyelit.com/

http://www.aptean.com/products/factory-mes

http://www.fasttrack365.com/

http://www.masterlock.com/more-from-master-lock/fieldid

http://www-03.ibm.com/software/products/en/filecontmana/

http://www.csc.com/

https://www.cgatechnology.com/

http://www.flinkiso.com/

http://www.formpipe.com/lifescience/

http://www.infor.com/product-summary/erp/fourth-shift/

http://www.fusionsystems.org/

http://www.gagecontrol.com/

http://www.indysoft.com/

http://www.gagelist.com/company.html

http://www.altegra.com/altegra_products1.htm

http://www.pqsystems.com/quality-solutions/gage-management/GAGEpack/

http://www.cybermetrics.com/

http://www.quickgmp.com/

http://www.grandavenue.com/

http://www.greenlight.guru/

http://www.gsqa.com/

http://www.halogensoftware.com/

http://hamsagars.net/hamsfd/hams.htm

http://www.hgint.com/

http://www.comply1.com/

http://www.healthstream.com/

http://www.highjump.com/solutions/manufacturing-execution

https://www.honeywellprocess.com/

http://www8.hp.com/in/en/software-solutions/quality-center-quality-management/

http://www.customerexpressions.com/cex/cexweb.nsf/HomeDisplay

http://www.ibaset.com/

http://www.idbs.com/en/platform-products/e-workbook/

http://www.ideagenplc.com/


Sponsored by 121


Adverse Events

Document Mgmt EHS


SPC / PAT


IBS US • • • • • • • • •iCOLOGIQ (formerly Quality Online) • • • • • • • • •IFS •IHS • • •iLearning (Seertech) •ImageWave •IN-CAL •IndustrySafe (TRA, Inc.) •Infinity QS •Infor • • • • • • •Infor EAMS •Infotehna • • • • • • • •Intelex • • • • • • • • •Interax Group • • • • • • • •Integrum Management Systems • • • • • •Intrastage • • • • •IQMS • • • • • • • • • •IQRC, Inc • • • • • • • •IQS, Inc. • • • • • • • • • •ISOLUCION S.A. • • • • • • • • • • •Isoma (E Squared UK) •isoTracker (Lenox Hill Ltd.) • • •IsoTrain (Softek) •isoXpress (AQA Company) •ISP Software Solutions • • • •IssueTrak •ISTM (Remedy) •iTac Software •JDA • •JD Edwards • • •JIRA (Atlassian) • • • • • •JobBOSS (Exact Business Software) • •Kalypso •Kintana (HP/Mercury Interactive) • •


http://www.ibs-us.com/

http://www.icologiq.com/

http://www.ifsworld.com/uk/solutions/ifs-applications/

https://www.ihs.com/products/product-change-management.html

http://seertechsolutions.com/ilearning-plus

http://www.imagewave.com/

http://www.in-cal.com/

http://www.industrysafe.com/

http://www.infinityqs.com/

http://www.infor.com/

http://www.infor.com/solutions/eam/

http://www.infotehna.com/

http://www.intelex.com/

https://interaxgrp.com/

http://www.integrumsystems.com/

http://www.intrastage.com/

http://www.iqms.com/

http://www.iqrc.com/

http://www.iqs.com/

http://web.isolucion.com.co/

http://www.isoma.systems/

http://www.lennoxhill.co.uk/

http://www.isotrain.com/

http://www.isoxp.com/00Home/IsoXpHome.aspx

http://www.ispsoftware-solutions.com/

http://www.issuetrak.com/

http://www.bmc.com/it-solutions/remedy-change-management.html

http://en.itac.de/

http://www.jda.com/

http://www.oracle.com/us/products/applications/jd-edwards-enterpriseone/overview/index.html

https://www.atlassian.com/

http://jobboss.exactamerica.com/

http://kalypso.com/services/product-lifecycle-management-plm-technology

http://www8.hp.com/us/en/software-solutions/ppm-it-project-portfolio-management/index.html?jumpid=va_rmvp19jtdi


Sponsored by 122


Adverse Events

Document Mgmt EHS


SPC / PAT


KMI •Knowledge Tree •Labsoft (Computing Solutions) •Labtronic / LABWORKS (PerkinElmer) •LabVantage • •LabWare (Waters) • •Learn.com (Oracle) •LearningPlus •Lighthouse Systems Limited •Lims1 (Ltech Australia Pty Ltd) •Liquent •Lotus Notes • •M3 (Rover Data Systems, LLC) • •Mainsaver •MAPEX Software • •MasterControl • • • • • • • • • • •Matrix Gemeni LIMS (Zumatrix/Autoscribe) •Maximo (IBM) •Medgate •MetricStream • • • • • • •mHelpDesk • •Micro Control Solutions • • • • • • • • • •Microsoft Dynamics •Microsoft Excel • • • • • • • • • • • • • • •Microsoft Navision • • • •Millennium III - M3 (Rover Data Systems, LLC) •Minitab •MIRS (A V Systems) •MPDV USA •Montrium • • • • • • •MSDSonline •Muddy Boots Software • •Neomatics • • • • •


https://www.ehs.com/

http://www.knowledgetree.com/

http://www.labsoftlims.com/

https://www.cambridgesoft.com/Ensemble_for_QA-QC/LimsLink/

http://www.labvantage.com/

http://www.labware.com/

https://www.oracle.com/applications/human-capital-management/talent-management/learning-development/index.html

http://www.learningplus.com/

http://www.lighthousesystems.com/

http://www.lims1.com/

https://www.parexel.com/solutions/informatics/regulatory-information-management/insight-product-service/

http://www-03.ibm.com/software/products/en/ibmnotes

http://www.roverdata.com/

http://www.mainsaver.com/

http://www.emapex.com/

http://www.mastercontrol.com/

http://www.autoscribeinformatics.com/about-us/matrix-gemini

http://www.ibm.com/software/products/en/maximoassetmanagement

http://www.medgate.com/

http://www.metricstream.com/

http://mhelpdesk.com/

http://www.microcontrolsolutions.com/

http://www.microsoft.com/en-in/dynamics/crm.aspx

https://products.office.com/en-us/excel

https://www.microsoft.com/en-us/dynamics/erp-nav-overview.aspx

http://www.roverdata.com/products.html

http://www.minitab.com/

http://www.mirsinfo.com/

http://www.mpdv-usa.com/

http://www.montrium.com/connect

http://www.msdsonline.com/

http://en.muddyboots.com/quality-control

http://www.neomatics.be/


Sponsored by 123


Adverse Events

Document Mgmt EHS


SPC / PAT


Neosystems •Net-Inspect •NetRegulus (PTC) • • •NetSuite •New Generation Computing, Inc. (NGC) • • •NextDocs • • • • • •Northwest Analytics (NWA) •Novatek International • • • • • • • • • •Noverant •NuGenesis Lab Management System (Waters Corp.) •Omnex • • • •OnePlace (Eclipse Computing Australia Pty Ltd) •Onyx (Aptean) •Open Mind Solutions • • • • • •Optiva PLM (Infor) • • •Oracle • • • • •Oracle Harvest •Pastel Auditor (Sage) •PDXpert PLM (Active Sensing) • • •PeopleSoft (Oracle) •Performix, Inc •Pharmschul (GMP Software) • •Pilgrim Quality Solutions • • • • • • • • •Pinnacle Business Solutions • •PIVOTAL (Aptean) •PlantNet (Altegra) •Plateau (SAP) •Plex Systems • •PMED (Oazez Software E Tecnologia) •PQ Systems • •Proactive Health and Safety Solutions •ProCAL (Prime Technologies) •


http://www.capterra.com/ehs-management-software/spotlight/136716/iTrak /NeoSystems

https://www.net-inspect.com/

http://www.ptc.com/

http://www.netsuite.com/portal/home.shtml

http://www.ngcsoftware.com/

http://www.nextdocs.com/

http://www.nwasoft.com/

http://www.ntint.com/

http://www.noverant.com/

http://www.waters.com/waters/en_US/NuGenesis-Lab-Management-System/nav.htm?cid=10067099&locale=en_US

http://www.omnex.com/

http://www.just1place.com/


http://www.open-mind-solutions.com/

http://www.infor.com/product-summary/plm/optiva/

http://www.oracle.com/

http://www.me.sagepastel.com/Other-Sage-Pastel-Products/Sage-Pastel-Auditor.asp

http://www.buyplm.com/

http://www.oracle.com/us/products/applications/peoplesoft-enterprise/overview/index.html

http://www.performixinc.com/

http://www.gmp-software.eu/

http://www.pilgrimquality.com/

http://www.pinsol.com/


http://www.altegra.com/altegra/plantnetspc.htm

http://www.elearninglearning.com/plateau/sap/

http://www.plex.com/

http://www.oazez.com.br/?page_id=5495

http://www.pqsystems.com/

http://www.phssolutions.ca/

http://www.primetechpa.com/


Sponsored by 124


Adverse Events

Document Mgmt EHS


SPC / PAT


ProcessPro •Prodac Systems •Product Vision (CA Technologies) •ProMation Systems Inc. (PSI) •ProntoForms •Prospecta Software •PSC Software • • • • • • • • • • • •Q5 Systems • • • •QAD • • • • • •QAI (Quality Institute of America) • • • • • • •QA Systems (QASYS) • • • • • •QMSrs Ltd • • • • • •QPR Software PLC • • •Q-Pulse (Gael) • • • • • • • •QT9 (World Quality Systems) • •QTi •QUAD (Aster Technologies) • • • •Qualio • • • • • •Qualisyst Ltd. •Qualitron Systems •Quality Link Software • • • • •Quality Systems Toolbox • • • • • • •Quality-Works (KvalitetsGruppen) • •Qualtrax • • • • • • •Quarta (Blulink) • • • •Qube Software •Qumas (Dassault Systemes) • • • • • • • •Rational (IBM) •Redmine • •Regula •Remedy ARS (BMC) • •Remedy Interactive • • •Rescop • • • • • • • •


http://www.processproerp.com/

http://www.prodacsystems.com/

https://support.ca.com/cadocs/0/CA Agile Vision and CA Product Vision Summer 2012-ENU/Bookshelf.html

http://www.promationsystems.com/

https://www.prontoforms.com/

http://www.prospecta.com/

http://www.pscsoftware.com/

http://www.q5systems.com/

http://www.qad.com/

http://www.qisssoftware.com/

http://www.qasys.com/solutions.aspx

http://www.qmsrs.com/qmsrsweb

http://www.qpr.com/

http://www.gaelquality.com/

http://qt9software.com/

http://www.w3conf.net/qtisoft.com

http://www.aster-technologies.com/?id=quad

http://www.qualio.com/

http://www.qsyst.com/qualisyst_en.htm

http://www.qualitronsystems.com/

http://qmsonline.com/

http://www.qualitysystems.com/

http://www.quality-works.com/

http://www.qualtrax.com/

http://www.blulink.com/

http://www.qubesoftware.org/

http://www.qumas.com/

http://www-03.ibm.com/software/products/en/ratichan/

http://www.redmine.org/

https://regulaforensics.com/en/products/software/regula-forensic-studio/

https://communities.bmc.com/community/bmcdn/bmc_remedy_ar_system

http://www.remedyinteractive.com/

http://www.rescop.com/


Sponsored by LinkedIn Quality & Regulatory

Network

125


Adverse Events

Document Mgmt EHS


SPC / PAT


ReSol Technologies • • • • • • • •Rivo Safeguard • • • • •Rockwell • •Ross ERP (Aptean) •Saba •Saeker Systems •Safefood 360 • • • • • • • • • • • •Safety Concepts Group •Safety Tracker Software • •SafetyReports.com •SafetySync • •Sage PLM • • •Salesforce • •Samanage •SAP • • • • • • • • • • • • •Seacoast Laboratory Data Systems Inc. •Seertech •Selerant • •Sercle QMS • • • • • •ServiceNOW • • • •SFS Chemical Safety •SharePoint (Microsoft) • • • • • • • • • •Siebel (Oracle) • •Siemens PLM • • • •SIMATIC (Siemens) • • •SimpleTrak (ION Quality Systems) • • • • • • • •Simply Safety (CCD Systems) •Sinerji (SoftTech A.S.) •Sirwill FBM (Global Quality Village) • •SISTRADE Solutions • • •SLIM (InterCAX) • •Smaat (Maerix) •SOAR Solutions •

http://www.resolsystems.com/

http://www.rivosoftware.com/

http://www.rockwellautomation.com/rockwellsoftware/overview.page

http://www.aptean.com/products/ross-erp/

http://www.saba.com/us/

http://www.saeker.co.uk/

https://safefood360.com/

http://www.safetactics.eu/scg/

http://www.safety-tracker.net/

http://safety-reports.com/

https://www.safetysync.com/

http://www.sage.com/us/erp

http://www.salesforce.com/

https://www.samanage.com/

http://www.sap.com/

http://www.sldsi.com/

https://www.seertechsolutions.com/

http://www.selerant.com/corp/

http://www.sercle.co.uk/

http://www.servicenow.com/

http://chemicalsafety.com/

https://products.office.com/en-us/sharepoint/collaboration

http://www.oracle.com/us/products/applications/siebel/overview/index.html

http://www.plm.automation.siemens.com/en_us/

http://w3.siemens.com/mcms/automation/en/automation-systems/industrial-automation/Pages/Default.aspx

http://www.ionqualitysystems.com/proof/

http://www.simplysafety.com/

http://www.softtech.com.tr/English/urunlerSinerji.asp

https://www.globalqualityvillage.com/

http://www.sistrade.com/en/home.htm

http://intercax.com/

http://www.maerix.com/en/home/

http://www.soarsolutionsinc.com/


Sponsored by 126


Adverse Events

Document Mgmt EHS


SPC / PAT


SoftExpert Software • • • • • • • • • • • •SofTech Inc. • •SoftTech Health LLC • • •Solabs • • • • • • •Sopheon • •Spiramid •SQL*LIMS •Star LIMS •SuccessFactors (SAP) •SumTotal •Sword Achiever • • • • • • •Symbion Systems, Inc. •Synergy (Zontec) •Syspro •Taleo (Oracle) •TeamMate Audit Management •TeamPage (Traction Software) • • •Tech-X (Cetex) • • •TEDS Inc. •The Lean Machine •The WERCS (UL) •Thermo Scientific (Darwin, Galileo, Nautilus, SampleManager, Watson) •Tip Technologies • • • • • • • • •Title21 Health Solutions • • • • • • • • •TMS (Collaborative Quality Systems) •TQS-9000 (ISP Software Solutions) • • •Trace One • •TrackPro •Trackwise (Sparta Systems) • • • • • • • •Training Tracker (Computer Directions) •TrakSYS (Parsec Automation) •TRIM Records Management (HP) •UniLab (Siemens) •



http://www.softech.com/

http://www.softtechhealth.com/Default

http://www.solabs.com/

https://www.sopheon.com/

http://spiramid.com/services/core/

http://www.labvantage.com/

http://www.starlims.com/en-us/home/

http://www.successfactors.com/en_us.html

http://www.sumtotalsystems.com/

http://www.sword-achiever.com/

http://www.gosymbion.com/

http://www.zontec-spc.com/

https://www.syspro.com/us/

http://www.oracle.com/us/products/applications/taleo/overview/index.html

http://www.teammatesolutions.com/audit-management.aspx

http://www.tractionsoftware.com/

http://www.tech-x.com/

http://teds.com/

http://www.theleanmachine.com/

http://ul-scs.com/

http://www.thermoscientific.com/en/home.html

http://www.tiptech.com/

http://www.title21health.com/

http://collaborativequality.com/

http://www.ispsoftware-solutions.com/TQSSoftware.htm

http://www.traceone.com/en/

http://trackpro.org/en/

http://www.spartasystems.com/

http://www.comdirections.com/training_tracker/home

http://www.parsec-corp.com/traksys

http://www8.hp.com/us/en/software-solutions/edrms-electronic-document-records-management-system/

http://w5.siemens.com/belux/web/en/industry/industry-solutions/industriele-it/LIMS/Pages/Default.aspx


Sponsored by 127


Adverse Events

Document Mgmt EHS


SPC / PAT


uniPoint Software • • • • • • • • • • • •uPerform (ANCILE) •

Ultimo • •

Veeva • • • • • • • • •

Velocity Software •

Verse Solutions • • • • • • • •

Vintara • • • • • • •

Visual Enterprise Solutions • •

Vivaldi Software • • • • • • •

V-Soft Computers •

Wavefront Software •

webOSCAR (Verdi Technology Assoc.) •

Werum Software & Systems •

Windchill Quality Suite (PTC) • • • • • •

Windchill PLM (PTC) • • • • • • •

WinSPC (DataNet Quality Systems) •

Wonderware (Invensys / Schneider Electric) • •

xTrak (usCalibration) •

ZenDoc (GetZenDoc) • • •

ZeraWare •

ZenQMS (formerly The QAB) • • • • • • • • •

Zumatrix (Autoscribe Informatics) •


http://www.unipointsoftware.com/

http://www.ancile.com/

http://www.capterra.com/cmms-software/spotlight/133215/Ultimo Maintenance Management/Ultimo Software Solutions

https://www.veeva.com/

http://www.velocity-software.com/

http://www.versesolutions.com/

http://www.vintara.com/index.html

http://visual-quality.com/default.aspx

http://www.vivaldisoftware.com/

http://v-softcomputers.com/about-us.html

http://www.wavefrontsoftware.com/

http://verditechnology.com/

http://www.werum.com/en/home.html

http://www.ptc.com/about/our-approach/process-expertise/quality-and-reliability-management

http://www.ptc.com/

http://www.winspc.com/products/winspc

http://software.schneider-electric.com/wonderware/

http://www.uscalibration.com/

http://www.getzendoc.com/

http://www.zeraware.com/

http://www.zenqms.com/

http://autoscribeinformatics.com/

