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![Page 1: Using HP Quality Center for Pharmaceutical automation and ... · Using HP Quality Center for validation in Pharmaceutical automation and IT projects 2016-03-10 Henrik Herborg Bay-Wedel](https://reader034.vdocument.in/reader034/viewer/2022042806/5f698381bb67816f674c6a69/html5/thumbnails/1.jpg)
Using HP Quality Centerfor validation in Pharmaceutical automation and IT projects
2016-03-10 Henrik Herborg Bay-Wedel
![Page 2: Using HP Quality Center for Pharmaceutical automation and ... · Using HP Quality Center for validation in Pharmaceutical automation and IT projects 2016-03-10 Henrik Herborg Bay-Wedel](https://reader034.vdocument.in/reader034/viewer/2022042806/5f698381bb67816f674c6a69/html5/thumbnails/2.jpg)
About the presenter
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Senior Quality Engineer
Henrik Herborg Bay-Wedel
Phone: +45 3079 1810
E-mail: [email protected]
• Senior Quality Engineer at NNE Pharmaplan
• 15 years experience in pharma manufacturing development and
pharma / automotive device development
• Validation of IT systems and production equipment
• 8 years with HPQC in Pharma
• Implementation and development of HPQC in Novo Nordisk
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Customer Novo Nordisk Product Supply
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• HP Quality Center +
• Novo Nordisk Template
• Customised for Pharma (GMP) use
• Genelogix Electronic Signature module
• GAMP 5 methodology
• Citrix
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Validation “V” model used on a risk based approach
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Advantages using HPQC for validation
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Fast to market
• Effectively reuse knowledge
• Controlled Validation / traceability (relation linking)
• Reduces ‘enormous’ amounts of paper (pharma)
• One platform for validation worldwide
• (Electronic signature)
• Real time, minor upload delay
• Who did what, when?
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Life cycle tool - HPQC
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Create/
update
Peer review
Review
Execute
Approve
Audits
Approve
Deviation
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HPQC model in Novo Nordisk
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• Diagram whiteboard
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Enable logical reuse – Requirements
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• Database functionality
• Agree categorisation
• Encourages short clear requirements
• Develop requirements using version control
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Two step approval of URS
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Enable logical reuse – Test Plan
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• Linking to scoped requirements
• Should be same categories as Requirements
• Encourages short clear Test Plans
• Develop Test Plans using version control
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Electronic signatures (ES) for smoother project execution
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Effort
Time
URS Protocol Test
Execution
Report
Normal pharma validation
HP QC with ES
Typical scenario
Extra
LessApprovalApproval
Approval
ESES
ES
ES
ES
ES
Work
Work
Work
Next phase
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Parallel execution and approval
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• E: Execution
• R: Review
• A: Approval
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Various status reports
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• Execution Status
• Requirement coverage status
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Prerequisites
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Training
• Different level Novo Nordisk courses
• User role o Validation resources
o Approver
o Tester
System Access
• Access control through general system access and
• Individual project access
IT Network
• Need stable network connection
Audit
Inspection readiness (pharma)
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Pit falls
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• HPQC not part of early project planning
• Lack of training
• Support for setting up HP QC folder structures
• Agreeing on naming conventions
• Support during project execution
• Conversion of paper URS documents
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Next steps
• Introduce use of HPQC for Design documentation
• Update to latest version HP ALM
My personal wishes
Add formal responsibility in organisation for
each category of Requirements
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Thank you - Questions?
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