IQVIA SmartSolve®'s Position Regarding the Requirements of EU: Volume 4 GMP – Annex 11
Mar 17, 2023

Most regulatory bodies have laws, regulations and guidelines relating to electronic records and electronic signatures. They also typically define requirements for the creation, modification, maintenance, archival, retrieval, and transmittal of electronic records. The European Commission's EudraLex – Volume 4, Good Manufacturing Practice, Annex 11: Computerised Systems, which took effect on June 30, 2011 is the requirements document for the aforementioned in Europe.

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