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Business Cases

PV Information Systems: Validation Global Review Thursday 21 January 2010

Customer :

 

Largest French independent pharmaceutical company: QA, Therapeutic Safety and IS departments

 

Context :

 

Global Review and PV Information Systems (IS) preparation to Health Authorities’ planned inspections (AFSAPPS, MHRA). In addition to the core PV system several complex interfaces had to be taken into account, including eCRF ones and an Eudralex E2B declaration gateway.

 

Objective :

 

To remediate and complete the existing computer system validation in order to bring it in compliance with international validation requirements and HA expectations (21 CFR Part 11, Europe GMP Annex 11, PIC/S….

 

Organization of the task:

• Global PV IS inventory and their« validated state » evaluation, workload estimation, prioritization and Global Validation Strategy elaboration according to current company procedure

• Coordination and implementation of “To do” actions

• Direct participation in validation tasks : document reviews, test protocol writing, test execution and follow up, Final Report Validation writing, deviation management, periodic reviews

• Accurate recommendations regarding Validation process in the complex and rapidly changing context of Electronic Records: Change management, Audit trail, System documentation, Quality operating procedure set up...

Resources applied :

 

1 Senior Consultant, previously CIO

1 junior Consultant, PhD
Length of the mission: 6 months

Results :

 

Objective achieved. Gaps closed.

The inspection went very satisfactorily