Navigating the Complexity of Life Science Compliance Riya Cao – Director Vertical Marketing, QAD Ray Greenwood, VP Consulting Services, Strategic Information

Navigating the Complexity of Life Science ComplianceRiya Cao – Director Vertical Marketing, QAD Ray Greenwood, VP Consulting Services, Strategic Information Group

Life Science Compliance

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The following is intended to outline QAD’s general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functional capabilities described for QAD’s products remains at the sole discretion of QAD.

Safe Harbor Statement


• Introductions• Compliance challenges• What is validation?• Planning your upgrade with validation in

mind• QAD life sciences update

Agenda


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• 600+ Accounts in 64 Countries • 21 New Accounts FY10• 24 New Accounts FY11• 27% Revenue increase FY11

QAD Life Sciences At-A-Glance


APAC18%

EMEA35%Lamer

7%

Namer40% Medical

Device51%

Pharma Biotech

37%

Other12%

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Regions Sectors

Life Sciences Sample Customers

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Meeting Life Sciences Industry Requirements


Customer Satisfaction

• Configured products

• After sales services• Returned goods• Complaints

Quality Accountability• Product safety• In-coming inspection • Supplier performance

Supply Chain Distribution• Contracts• Packaging & labeling• EDI

Regulatory Compliance• cGMP• FDA 21 CFR Part 11 • European Commission Annex 11• ePedigree• GAAP, SOX, IFRS

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SuppliersFinished Product

Mfgr

Distribution Channels

Customers

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Winner of Best White Papers Category

http://www.qad.com/erp/Life-Sciences/

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• Security• Audit trails• Electronic signatures• Training• Supporting procedural infrastructure• Computer system validation

21 CFR Part 11 / Annex 11


• Enhanced security• Audit trails• E-Signatures

QAD Enhanced Controls


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QAD Enterprise Applications QAD Enhanced Controls

Audit trails e-SignaturesEnhanced security

Sarbanes-Oxley infrastructure

21 CFR Part 11

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21 CFR Part 11 / Annex 11Life Science Compliance

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Training & Procedural Control


Life Sciences Easy On Boarding

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• 25 processes• 230+ Work Instructions• 137 Compliance points • 30 Training links

Training & Procedural Control

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21 CFR Part 11 / Annex 11Life Science Compliance

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What is Validation? Proof That a System Is “Performing As Designed”

STRATEGIC INFORMATION GROUPQAD Validation Product Partner

All production and/or quality system software should have documented requirements that fully define its intended use, and information against which testing results and other evidence can be compared, to show

that the software is validated for its intended use

Food & Drug Administration

A Definition for FDA Validation


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• System development lifecycle policy for computer related systems- SOP describing the lifecycle for the acquisition, development, implementation,

upgrade and retirement of software applications and computerized systems.

• User specification/requirements-high level- Created as an aide for the software selection process

• Computer system validation plan- Is system specific and defines the scope, approach, tasks, roles, responsibilities,

testing environment and acceptance criteria for the computer system.

• Hardware Installation Qualification (IQ) protocol- Verify and document that all critical aspects of the server installation adheres to

company specifications and manufacturer’s specifications.

• Software Installation Qualification (IQ) protocol- The purpose of this protocol is to provide documented evidence to a high degree

of assurance that the QAD enterprise applications software application has been installed in accordance with vendor specifications and company requirements.

Validation Deliverables and Definitions


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• Configuration baseline- Modules implemented

- Control file settings

- GMP related item status codes, inventory status codes

- Sets the stage for change control

• System design requirements- Define the intended use of the system

- Generated by evaluating user requirements against intended use of QAD, cGxP and Sarbanes-Oxley requirements.

- If the software is configurable, off the shelf software, and the configuration will be done in an iterative fashion, the software design specification may be omitted.

• Functional requirements- Define the intended use of the system.

- Generated by evaluating the user specification/requirements document against the intended use of the system.

- Describe the functions that the system will perform.



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• Functional specification- Define the intended use of the system in support of the functional requirements

- Process flows/design document

• Part 11 assessment- 21 CFR part 11 compliance assessment

• Risk assessment/hazard analysis- Identify and evaluate cGxP risks for the QAD ERP system.

• Operational Qualification (OQ) protocol/test scripts- Provide documented verification that a system operates according to written and

pre-approved specifications throughout all specified operating ranges and may include testing outside operational ranges.

- Discrete test scripts

• Performance Qualification (PQ) protocol/test scripts- Provide documented verification that the system is capable of performing and

controlling the activities of the process it is required to perform or control while operating in its specified operating environment.



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• Stress test- Verify and document that the QAD system performance is acceptable to all

company locations while operating under typical load conditions.

• Traceability matrix- Matrix that ties user requirements, functional requirements, user instructions, OQ

test scrip document ID and test number.

• Data migration Installation Qualification (IQ) protocol/test scripts- The IQ provides documented evidence that cGxP related data was successfully

loaded by comparing source and target reports/files.

• Validation final report- Review/summary of all validation deliverables. Sign-off that the system is

approved.



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STRATEGIC INFORMATION GROUPQAD Validation Product Partner

Planning Your Upgrade With Validation In Mind

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• Determine scope- Technical upgrade only with new .NET UI and

QAD EE• Rely on QAD release notes for guidance on

enhancements with potential compliance impacts• Rely on QAD ECO information for guidance on fixes

with potential compliance impacts

- Upgrade and implement new modules/functionality

Validation Approaches When Upgrading


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• Option A: Revalidate everything- Draft required new/revised cGxP related functional

requirements.- Identify previous functional requirements that may be

affected by product enhancements or eco’s.- Combine the above with previous functional

requirements- Perform risk assessment on all of the above functional

requirements.- Write and execute OQ protocol/test scripts for medium

or high risk requirements- Re-execute PQs.



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• Option B: Leverage previous validation packages- Draft required new/revised cGxP related functional

requirements.- Identify previous functional requirements that may have

be affected by product enhancements or ECO’s.- Perform risk assessment on the above new/revised or

affected functional requirements.- Write and execute OQ protocol/test scripts for medium

or high risk requirements- Re-execute PQs.



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Where Do I Find Release Notes and ECO Information?


• support.qad.com

QAD Release Notes

Computer System Validation

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QAD Release Notes


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QAD Release Notes Sample


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QAD ECO Information


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QAD ECO Information


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• Computer systems validation plan• Hardware installation qualification• Software installation qualification• User/functional requirements

Validation Deliverables to Consider


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• Risk assessment• Operational qualification protocol/test

scripts• Performance qualification protocol/test

scripts• Baseline configuration

Validation Deliverables To Consider


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• Backup & restore protocol/test scripts• Traceability matrix• Stress test• Data migration plan/protocol

- Possibly was not part of the initial validation

• Validation final report

Validation Deliverables to Consider


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QAD Life Sciences Update


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Serialization


Packaging LineProduct Serialization

EPCIS

Data Collection

Print Packer/Case/Pallet

labels

Wholesaler EPCIS

Distributor EPCIS

Retailer EPCIS

RxASN

Wholesaler ERP

Distributor ERP

Retailer ERP

ePedigree

ePedigree

Pedigree Messaging

Serialized Inventory

Mgmt

Pick/Pack/Ship

• Qualified environment including- Qualified IT infrastructure

• Hardware (IQ/IR)• Operation systems (IQ/IR )• QAD enterprise applications (IQ/IR)

- Qualified processes• 18 SOPs

- Qualified personnel• Extensive experience in admin & network• Employees trained to SOPs• Training records

On Demand LS Edition


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Corrective and Preventative

Actions

Records, Documents,

Change Controls

Equipment and Facility Controls

Production and Process Controls

Material Controls

Design Controls

Meeting FDA QS Requirements


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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm

EAMQAD EA

QMS

PLM QAD EA

QMS

QAD EA

Management

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm

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Metrics Affected


Process Benefit Value• On Demand Risk mitigation

ScalabilityQualified environment

ComplianceBest practice IT Administration

•Computer System Validation

CFR21 Part 11 Compliance

Risk basedIndustry validation best practice

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• Ask your account manager to arrange an Upgrade Q−Scan

• On Demand Q−Scan• Stop by the Strategic booth• Attend Thursday morning QMS

presentation• QAD Life Sciences website


Next Steps



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• Riya Cao: [email protected]• Ray Greenwood: [email protected]

Questions & Answers


mailto:[email protected]

mailto:[email protected]

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