The Singaporean division of a global diagnostics equipment manufacturer engaged SeerPharma to deliver training on Computer Software Assurance/Validation and 21 CFR Part 11. Multiple workshops were delivered to over 50 staff, to help them appreciate the regulatory expectations of the US FDA , for the work performed on-site.
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.
Copyright © SeerPharma
