Using HP Quality Centerfor validation in Pharmaceutical automation and IT projects

2016-03-10 Henrik Herborg Bay-Wedel

About the presenter

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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

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• 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

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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?

Life cycle tool - HPQC

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Create/

update

Peer review

Review

Execute

Approve

Audits

Approve

Deviation

HPQC model in Novo Nordisk

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• Diagram whiteboard

Enable logical reuse – Requirements

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• Database functionality

• Agree categorisation

• Encourages short clear requirements

• Develop requirements using version control

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

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

Parallel execution and approval

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• E: Execution

• R: Review

• A: Approval

Various status reports

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• Execution Status

• Requirement coverage status

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)

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

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?

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