OVERVIEW The purpose of this survey was to collect data from life sciences companies on the 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 75,000 professionals worldwide. Over 342 members from the Life Sciences industry participated.

Key Findings:

• Although many enabling technologies are available for both small and global companies, the majority of organizations still use manual methods to track and manage their Quality Management System.

• Many participants commented on the challenge on configuring and sustaining quality software especially globally. However, more than 42% do use enabling technology for managing many aspects of their quality systems.

Listing of all Software Vendors mentioned by participants in this survey can be found in the Appendix.

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

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.

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DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY, COMPANY

ANNUAL REVENUE AND THEIR ROLE OR FUNCTION WITHIN THE COMPANY

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INTERNAL/EXTERNAL AUDIT

4

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OTHERS

(from comments): Arena PLM

Audit Utopia

Entropy

CIQA

CloudForge

Compliance Control

Centre

Documentum

Ensur

LabExpert

Lotus Notes

Microsoft Navision

NextDocs

QAAD

QAB

QUIPS

ServiceNow

STEMSOFT

Title 21

Veeva

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CAPA

5

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS (fro m co mme nts):

Arena PLM

Bugzilla

CIQA

CloudForge

Compliance Control Centre

Compliancewire

Documentum

Entropy

Lotus Notes

NovaTek

Quads

QPR

Service Now

SOLABS

STEMSOFT

Veeva

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CHANGE CONTROL

6

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS (fro m co mme nts):

Arena PLM

Bugzilla

CIQA

CloudForge

Compliance Control Centre

Documentum

Entropy

Epicor Dataflo

IBM Rational

LabExpert

Lotus Notes

ManageEngine

NextDocs

Novatek

Quads

Sharepoint

Siemens TeamCenter

STEMSOFT

Veeva

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COMPLAINTS

7

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS (fro m co mme nt):

Arena PLM

Bugzilla

CIQA

CloudForge

Compliance Control Centre

Compliancewire

CTQ Software

Documentum

Entropy

IQMS

LabExpert

Lotus Note

PQMS 6P

Quads

Savant

ServiceNow

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DOCUMENT MANAGEMENT

8

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS

(fro m co mme nts):

CIQA

CloudForge

Compliance Control Centre

Ensur

Entropy

Epiware

LabExpert

NovaTek

Regula

STEMSOFT

Vivaldi

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EXCEPTIONS

9

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS

(fro m co mme nts):

Blue Mountain

CIQA

CloudForge

Compliance Control Centre

Compliancewire

Entropy

Epiware

Kintana

Lotus Notes

NextDocs

NovaTek

Quads

ServiceNow

STEMSOFT

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LABORATORY MANAGEMENT

10

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS

(fro m co mme nts):

H&A Scientific SLIM

Lotus Notes

Maximo

Oracle

SAP

Siemens (UniLab)

Zumatrix

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TRAINING

11

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS

(fro m co mme nts):

CIQA

CloudForge

Compliance Control Centre

Dokeos

Ensur

Entropy

HealthStream

iLearn

Learning Plus

Lotus Notes

NextDocs

NovaTek

Noverant LMS

STEMSOFT

Veeva

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SUPPLIER QUALITY

12

Only represents those vendors that had selections from the entire list.

*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

OT HERS

(fro m co mme nts):

Arena PLM

CIQA

CloudForge

Compliance Control Centre

Ensur

Entropy

Lotus Notes

MS Navision

Omnify

Pharmschul

Savant

SharePoint

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ADDITIONAL COMMENTS BY PARTICIPANTS

“Sometimes getting started is the hardest part. A good systems evaluation will always get the ball rolling”

“There is no a one system that can help you to manage your quality management system.”

“Integration is key.”

“Trouble making business case for quality related technology.”

“Commercial systems are complicated and not very intuitive. Always need customization (extra time and cost) and cost more than original quotes.”

“If done correctly and with one system, the system can deliver the Annual Report for each product within hours instead of weeks if done manually.”

“Global processes are challenging to create, deploy and maintain.”

“People sometimes forget how / what they have to do and so leave it, then the efficiency of the system does not work.”

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ADDITIONAL COMMENTS BY PARTICIPANTS

“Understand your processes and linkages and spend time mapping them out and improving them before turning to technology.”

“My company will introduce company wide SW platforms for these topics in the coming 1-2 years, as part of a Quality improvement program.”

“Software tools are great, but the downfall I have found with multiple systems is the initial configuration that causes problems once in use. It is well worth the time and effort engaging the software vendors early and getting robust feedback from your sites regarding how the system will be used in 5 years time to ensure that the configuration is thought through properly. Usually the system gets blamed for the problems a company has when it was the set up and knowledge regarding how it was to be used that was at fault.”

“The full benefits of introducing an enabling technology are difficult to define but also, the costs of implementation and maintenance are often not well understood ( training and validation in particular).”

“PLM seems like the trend to integrate all business.”

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TOTAL LIST OF VENDOR SOFTWARE COMPANIES

16

123Compliance Dassault (MatrixOne, Enovia) Liberty Labs (TrainTrack) Saba

Accelrys DevTech (Pathlore) Lotus Notes Salesforce.com

Agile (Oracle) Documentum ManageEngine SAP (QM, Plateau, SuccessFactors)

Arena Solutions Dokeos MasterControl (QAAD) Savant Software

Aris Global Eduneering MetricStream (QualityStream) ServiceNow

AssurX Epicor Microsoft Navision SharePoint

Blaze Systems Epiware Mystic Management Systems (Ensur) Siemens (TeamCenter,UniLab)

Blue Mountain ETQ need ot look up company name and product Solabs

BLU-e-CAT Synergy GMP Software GmbH (Pharmschul) NextDocs Sparta Systems (Trackwise)

BSI (Entropy) H&A Scientific (SLIM) Novatek International StarLIMS

Bugzilla HealthStream Noverant STEMSOFT

Cama Software HP Software (Kintana) Omnify Software SumTotal

CambridgeSoft IBM (FileNet Maximo, Rationale) Oracle (Agile, Argus, PeopelSoft, Quality, Siebel) Sword Achiever

Camstar IBS Orcle (iLearn) TEDS Inc.

Cebos Intelex Partner Point (Grand Avenue) Thermo Scientific

CIMCON Software (eTraininfo) Invensys (Wonderware) Pilgrim Software Title 21

CIQA IQS PQMS 6P Veeva

CloudForge IQMS PSC Software (Audit Utopia) Zumatrix

Compliance Control Centre ISOTrain PTC (NetRegulus, NetRM, Global Quality, Windchill)

Compliance360 ISS AG (Regula) QIS (Quads)

Compliancewire LabExpert Q-Pulse

CoreLIMS Labtronics QPR Software

Cornerstone LabVantage Quality Advisory Board (QAB)

CSC (FirstDoc) LabWare Qumas

CTQ Software LearningPlus Rockwell

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