View
3
Download
0
Category
Preview:
Citation preview
Using HP Quality Centerfor validation in Pharmaceutical automation and IT projects
2016-03-10 Henrik Herborg Bay-Wedel
About the presenter
2
Senior Quality Engineer
Henrik Herborg Bay-Wedel
Phone: +45 3079 1810
E-mail: HHBW@nnepharmaplan.com
• 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
Customer Novo Nordisk Product Supply
3
• HP Quality Center +
• Novo Nordisk Template
• Customised for Pharma (GMP) use
• Genelogix Electronic Signature module
• GAMP 5 methodology
• Citrix
Validation “V” model used on a risk based approach
4
Advantages using HPQC for validation
5
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?
Life cycle tool - HPQC
6
Create/
update
Peer review
Review
Execute
Approve
Audits
Approve
Deviation
HPQC model in Novo Nordisk
7
• Diagram whiteboard
Enable logical reuse – Requirements
8
• Database functionality
• Agree categorisation
• Encourages short clear requirements
• Develop requirements using version control
Two step approval of URS
9
Enable logical reuse – Test Plan
10
• Linking to scoped requirements
• Should be same categories as Requirements
• Encourages short clear Test Plans
• Develop Test Plans using version control
Electronic signatures (ES) for smoother project execution
11
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
Parallel execution and approval
12
• E: Execution
• R: Review
• A: Approval
Various status reports
13
• Execution Status
• Requirement coverage status
Prerequisites
14
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)
Pit falls
15
• 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
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
Thank you - Questions?
17
Recommended