Life Science Compliance
Navigating the Complexity of Life Science
Compliance
Riya Cao – Director Vertical Marketing, QAD
Ray Greenwood, VP Consulting Services, Strategic Information Group
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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.
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Life Science Compliance
Agenda
Introductions
Compliance challenges
What is validation?
Planning your upgrade with validation in
mind
• QAD life sciences update
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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
Namer
40%
Lamer
7%
APAC
18%
EMEA
35%
Sectors
Other
12%
Pharma
Biotech
37%
Medical
Device
51%
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Life Sciences Sample Customers
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Life Science Compliance
Meeting Life Sciences Industry Requirements
Regulatory Compliance
• cGMP
• FDA 21 CFR Part 11
• European Commission Annex 11
• ePedigree
• GAAP, SOX, IFRS
Suppliers
Quality Accountability
• Product safety
• In-coming inspection
• Supplier performance
Finished
Product
Mfgr
Customer Satisfaction
• Configured
products
• After sales services
• Returned goods
• Complaints
Distribution
Channels
Customers
Supply Chain Distribution
• Contracts
• Packaging & labeling
• EDI
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Winner of Best White Papers Category
http://www.qad.com/erp/Life-Sciences/
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Life Science Compliance
21 CFR Part 11 / Annex 11
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Security
Audit trails
Electronic signatures
Training
Supporting procedural infrastructure
Computer system validation
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Life Science Compliance
QAD Enhanced Controls
• Enhanced security
• Audit trails
• E-Signatures
QAD Enterprise Applications
Enhanced
security
QAD Enhanced Controls
Audit trails
e-Signatures
Sarbanes-Oxley infrastructure
21 CFR Part 11
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Life Science Compliance
21 CFR Part 11 / Annex 11
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Security
Audit trails
Electronic signatures
Training
Supporting procedural infrastructure
Computer system validation
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Life Science Compliance
Training & Procedural Control
Life Sciences Easy On Boarding
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Training & Procedural Control
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25 processes
230+ Work Instructions
137 Compliance points
30 Training links
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Life Science Compliance
21 CFR Part 11 / Annex 11
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Security
Audit trails
Electronic signatures
Training
Supporting procedural infrastructure
Computer system validation
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STRATEGIC INFORMATION GROUP
QAD Validation Product Partner
What is Validation? Proof That a System Is
“Performing As Designed”
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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
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Life Science Compliance
Validation Deliverables and Definitions
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System development lifecycle policy for computer related systems
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User specification/requirements-high level
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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
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Created as an aide for the software selection process
Computer system validation plan
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SOP describing the lifecycle for the acquisition, development, implementation,
upgrade and retirement of software applications and computerized systems.
Verify and document that all critical aspects of the server installation adheres to
company specifications and manufacturer’s specifications.
Software Installation Qualification (IQ) protocol
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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.
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Life Science Compliance
Validation Deliverables and Definitions
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Configuration baseline
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Modules implemented
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Control file settings
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GMP related item status codes, inventory status codes
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Sets the stage for change control
System design requirements
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Define the intended use of the system
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Generated by evaluating user requirements against intended use of QAD, cGxP and
Sarbanes-Oxley requirements.
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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
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Define the intended use of the system.
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Generated by evaluating the user specification/requirements document against the
intended use of the system.
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Describe the functions that the system will perform.
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Life Science Compliance
Validation Deliverables and Definitions
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Functional specification
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Define the intended use of the system in support of the functional requirements
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Process flows/design document
Part 11 assessment
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Risk assessment/hazard analysis
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21 CFR part 11 compliance assessment
Identify and evaluate cGxP risks for the QAD ERP system.
Operational Qualification (OQ) protocol/test scripts
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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.
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Discrete test scripts
Performance Qualification (PQ) protocol/test scripts
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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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Life Science Compliance
Validation Deliverables and Definitions
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Stress test
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Traceability matrix
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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
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Verify and document that the QAD system performance is acceptable to all
company locations while operating under typical load conditions.
The IQ provides documented evidence that cGxP related data was successfully
loaded by comparing source and target reports/files.
Validation final report
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Review/summary of all validation deliverables. Sign-off that the system is approved.
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STRATEGIC INFORMATION GROUP
QAD Validation Product Partner
Planning Your Upgrade With Validation In Mind
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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
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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.
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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.
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Life Science Compliance
Where Do I Find Release Notes and ECO Information?
• support.qad.com
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Computer System Validation
QAD Release Notes
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Computer System Validation
QAD Release Notes
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Computer System Validation
QAD Release Notes Sample
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Life Science Compliance
QAD ECO Information
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Life Science Compliance
QAD ECO Information
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Life Science Compliance
Validation Deliverables to Consider
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Computer systems validation plan
Hardware installation qualification
Software installation qualification
User/functional requirements
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Life Science Compliance
Validation Deliverables To Consider
• Risk assessment
• Operational qualification protocol/test
scripts
• Performance qualification protocol/test
scripts
• Baseline configuration
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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
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Life Science Compliance
QAD Life Sciences Update
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Life Science Compliance
Serialization
ePedigree
Wholesaler EPCIS
Pedigree
Messaging
EPCIS
Data
Collection
ePedigree
Retailer EPCIS
Serialized
Inventory
Mgmt
Packaging Line
Product Serialization
Distributor EPCIS
Pick/Pack/
Ship
Wholesaler ERP
Print Packer/
Case/Pallet
labels
Distributor ERP
RxASN
Retailer ERP
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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
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Life Science Compliance
Meeting FDA QS Requirements
QMS
Corrective and
Preventative
Actions
PLM
QAD EA
Production and
Process Controls
Design Controls
Management
Equipment and
Facility Controls
Material Controls
QAD EA
Records,
Documents,
Change Controls
QAD EA
EAM
QMS
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
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Life Science Compliance
Metrics Affected
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
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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
http://www.qad.com/erp/Life-Sciences/
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Life Science Compliance
Questions & Answers
• Riya Cao: zrc@qad.com
• Ray Greenwood: rayg@strategic.com
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www.qad.com
© QAD Inc
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