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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
Life Science Compliance
• Introductions• Compliance challenges• What is validation?• Planning your upgrade with validation in
mind• QAD life sciences update
Agenda
Life Science Compliance
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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
Life Science Compliance
APAC18%
EMEA35%Lamer
7%
Namer40% Medical
Device51%
Pharma Biotech
37%
Other12%
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Regions Sectors
Meeting Life Sciences Industry Requirements
Life Science Compliance
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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• Security• Audit trails• Electronic signatures• Training• Supporting procedural infrastructure• Computer system validation
21 CFR Part 11 / Annex 11
Life Science Compliance
• Enhanced security• Audit trails• E-Signatures
QAD Enhanced Controls
Life Science Compliance
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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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• Security• Audit trails• Electronic signatures• Training• Supporting procedural infrastructure• Computer system validation
21 CFR Part 11 / Annex 11Life Science Compliance
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• 25 processes• 230+ Work Instructions• 137 Compliance points • 30 Training links
Training & Procedural Control
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• Security• Audit trails• Electronic signatures• Training• Supporting procedural infrastructure• Computer system validation
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
Life Science Compliance
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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
Life Science Compliance
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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.
Validation Deliverables and Definitions
Life Science Compliance
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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.
Validation Deliverables and Definitions
Life Science Compliance
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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.
Validation Deliverables and Definitions
Life Science Compliance
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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
Life Science Compliance
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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.
Validation Approaches When Upgrading
Life Science Compliance
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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.
Validation Approaches When Upgrading
Life Science Compliance
• Computer systems validation plan• Hardware installation qualification• Software installation qualification• User/functional requirements
Validation Deliverables to Consider
Life Science Compliance
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• Risk assessment• Operational qualification protocol/test
scripts• Performance qualification protocol/test
scripts• Baseline configuration
Validation Deliverables To Consider
Life Science Compliance
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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
Life Science Compliance
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Serialization
Life Science Compliance
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
Life Science Compliance
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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
Life Science Compliance
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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
EAMQAD EA
QMS
PLM QAD EA
QMS
QAD EA
Management
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Metrics Affected
Life Science Compliance
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
http://www.qad.com/erp/Life-Sciences/
Next Steps
Life Science Compliance
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• Riya Cao: [email protected]• Ray Greenwood: [email protected]
Questions & Answers
Life Science Compliance