While we increasingly rely on computerised systems in our everyday GMP operations, the systems we use have evolved significantly over time and continue to evolve at an unprecedented pace. It is certainly challenging to keep up with the multitude of changes and increasing complexity in the functionality, connectivity and interoperability of...
Artificial Intelligence (AI) is reshaping industries worldwide, and life sciences is no exception. From drug discovery to clinical decision support, AI has the potential to transform the development, testing, and delivery of therapies. Yet, while the promise is immense, adoption remains cautious. The road ahead requires striking a balance between...
Audit trails play a crucial role in ensuring data integrity, traceability and compliance with Good Manufacturing Practice (GMP) regulations. Under the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16), Annex 11 outlines specific requirements for computerised systems, emphasising the need for audit trail reviews....
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.
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