What is a computerised system?

18.10.2021

Question of the Week

A computerised system consists of the hardware, software and network components, together with the controlled functions and associated documentation. (Definition ISPE GAMP® 5 Guide)

[GMP Compliance Adviser, Chapter 9.C]

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EMA: New Q&A for Co-Processed Excipients

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The EMA has published new Questions & Answers on co-processed excipients (CoPEs) used in solid oral dosage forms, introducing a harmonised, risk-based regulatory approach applicable to human and veterinary medicines.

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The EMA has published new Questions & Answers on the use of the Product Lifecycle Management (PLCM) document, clarifying its role within the EU variations framework for post-approval quality changes.

What is the Data Lifecycle?

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