A major pharmaceutical distribution organisation engaged the services of SeerPharma (Singapore) Pte Ltd to provide a review on the compliance of its core SAP-Centric solution to the GxP Computer Systems Validation (CSV) requirements of both FDA 21 CFR Part 11 and PIC/S Guide to GMP Annex 11. There were 2 phases to this project.
Phase 1 - CSV Gap Assessment and Remediation Plan:
SeerPharma assessed the documentation of the client's regional and local systems (validation documentation and supporting IT governance procedures). This assessment was performed over 2 weeks, and a gap analysis report with remediation plan was provided.
Phase 2 – Remediation Consulting:
The client decided to close these gaps and bring the CSV documentation up to an appropriate level of compliance. To achieve this, SeerPharma provided CSV training to IT Management, Project and Support teams. With SeerPharma’s guidance, the client generated CSV Policies and a Computerised Systems Master Validation Plan. The organisation has followed the processes required to document and provide evidence to validate their core SAP-Centric solution.
“Thanks. I am very grateful for the help you gave us. I learnt a lot.” - Senior Director
Contact us if you’d like to discuss your computer system validation (CSV) concerns, like PIC/S Annex 11 compliance, and how SeerPharma can help you address them.
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This post comes from our July 2016 Journal. You may also be interested in these posts:
- Effective Computer System Validation (CSV) in the Pharmaceutical and Medical Device Industries
- CSV Support for Medical Device Manufacturer