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.
SeerPharma assists a multinational pharmaceutical company with on-site GMP validation activities.
A major Australian manufacturer of medical devices has engaged with SeerPharma to deliver a customised program on computer system validation (CSV). The course looks to address content such as agile processes, cloud computing and automated testing drawing on SeerPharma’s experience with the regulatory (GMP) framework and incorporating case studies...
You’re a Quality, IT, or Operational manager working for a Pharmaceutical / Medical Device company, responsible for the computer systems used in-house. Working in the Pharmaceutical / Medical Device industry, means that regulators such as the FDA and TGA will scrutinise the use and validation of these business critical systems.
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