1. Navigating the Complexity of Life Science Compliance
Riya Cao – Director Vertical Marketing, QAD
Ray Greenwood, VP Consulting Services, Strategic Information Group 1 1

2. Life Science Compliance
Safe Harbor Statement
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.

3. Agenda Introductions Compliance challenges What is validation?
Life Science Compliance
Agenda
Introductions
Compliance challenges
What is validation?
Planning your upgrade with validation in mind
QAD life sciences update

4. QAD Life Sciences At-A-Glance
Life Science Compliance
QAD Life Sciences At-A-Glance
600+ Accounts in 64 Countries
21 New Accounts FY10
24 New Accounts FY11
27% Revenue increase FY11
Regions
Sectors

5. Life Sciences Sample Customers

6. Meeting Life Sciences Industry Requirements
Life Science Compliance
Meeting Life Sciences Industry Requirements
Regulatory Compliance
cGMP
FDA 21 CFR Part 11
European Commission Annex 11
ePedigree
GAAP, SOX, IFRS
Customer Satisfaction
Configured products
After sales services
Returned goods
Complaints
Suppliers
Finished Product
Mfgr
Distribution Channels
Customers
Quality Accountability
Product safety
In-coming inspection
Supplier performance
Supply Chain Distribution
Contracts
Packaging & labeling
EDI

7. Winner of Best White Papers Category

8. 21 CFR Part 11 / Annex 11 Security Audit trails Electronic signatures
Life Science Compliance
21 CFR Part 11 / Annex 11
Security
Audit trails
Electronic signatures
Training
Supporting procedural infrastructure
Computer system validation

9. QAD Enterprise Applications
Life Science Compliance
QAD Enhanced Controls
Enhanced security
Audit trails
E-Signatures
QAD Enterprise Applications
QAD Enhanced Controls
Enhanced security
Audit trails
e-Signatures
Sarbanes-Oxley infrastructure
21 CFR Part 11

10. 21 CFR Part 11 / Annex 11 Security Audit trails Electronic signatures
Life Science Compliance
21 CFR Part 11 / Annex 11
Security
Audit trails
Electronic signatures
Training
Supporting procedural infrastructure
Computer system validation

11. Training & Procedural Control
Life Science Compliance
Training & Procedural Control
Life Sciences Easy On Boarding

12. Training & Procedural Control
25 processes
230+ Work Instructions
137 Compliance points
30 Training links

13. 21 CFR Part 11 / Annex 11 Security Audit trails Electronic signatures
Life Science Compliance
21 CFR Part 11 / Annex 11
Security
Audit trails
Electronic signatures
Training
Supporting procedural infrastructure
Computer system validation

14. What is Validation? Proof That a System Is “Performing As Designed”
STRATEGIC INFORMATION GROUP
QAD Validation Product Partner
What is Validation? Proof That a System Is “Performing As Designed”

15. A Definition for FDA Validation
Life Science Compliance
A Definition for FDA Validation
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

16. Validation Deliverables and Definitions
Life Science Compliance
Validation Deliverables and Definitions
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.

17. Validation Deliverables and Definitions
Life Science Compliance
Validation Deliverables and Definitions
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.

18. Validation Deliverables and Definitions
Life Science Compliance
Validation Deliverables and Definitions
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.

19. Validation Deliverables and Definitions
Life Science Compliance
Validation Deliverables and Definitions
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.

21. Planning Your Upgrade With Validation In Mind
STRATEGIC INFORMATION GROUP
QAD Validation Product Partner
Planning Your Upgrade With Validation In Mind

22. Validation Approaches When Upgrading
Life Science Compliance
Validation Approaches When Upgrading
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

23. Validation Approaches When Upgrading
Life Science Compliance
Validation Approaches When Upgrading
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.

24. Validation Approaches When Upgrading
Life Science Compliance
Validation Approaches When Upgrading
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.

25. Where Do I Find Release Notes and ECO Information?
Life Science Compliance
Where Do I Find Release Notes and ECO Information?
support.qad.com

26. Computer System Validation
QAD Release Notes

27. Computer System Validation
QAD Release Notes

28. QAD Release Notes Sample
Computer System Validation
QAD Release Notes Sample

29. Life Science Compliance
QAD ECO Information

30. Life Science Compliance
QAD ECO Information

31. Validation Deliverables to Consider
Life Science Compliance
Validation Deliverables to Consider
Computer systems validation plan
Hardware installation qualification
Software installation qualification
User/functional requirements

32. Validation Deliverables To Consider
Life Science Compliance
Validation Deliverables To Consider
Risk assessment
Operational qualification protocol/test scripts
Performance qualification protocol/test scripts
Baseline configuration

33. Validation Deliverables to Consider
Life Science Compliance
Validation Deliverables to Consider
Backup & restore protocol/test scripts
Traceability matrix
Stress test
Data migration plan/protocol
Possibly was not part of the initial validation
Validation final report

34. QAD Life Sciences Update
Life Science Compliance
QAD Life Sciences Update 34

35. Life Science Compliance
Serialization

36. On Demand LS Edition Qualified environment including
Life Science Compliance
On Demand LS Edition
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

37. Meeting FDA QS Requirements
Life Science Compliance
Meeting FDA QS Requirements
QMS
Corrective and Preventative Actions
PLM
QAD EA
Design Controls
Production and Process Controls
Management
Material Controls
Equipment and Facility Controls
QAD EA
EAM
Records, Documents, Change Controls
QAD EA
QMS

38. Metrics Affected Life Science Compliance Process Benefit Value
On Demand
Risk mitigation
Scalability
Qualified environment
Compliance
Best practice IT Administration
Computer System Validation
CFR21 Part 11 Compliance
Risk based
Industry validation best practice

39. Next Steps Ask your account manager to arrange an Upgrade Q−Scan
Life Science Compliance
Next Steps
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

40. Questions & Answers Riya Cao: zrc@qad.com
Life Science Compliance
Questions & Answers
Riya Cao:
Ray Greenwood:

41.
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