The EEC has adopted Guidelines on Data Integrity and Validation of Computerized Systems

ECE 19 September 2023 18:08

The Board of the Eurasian Economic Commission has adopted Guidelines on Ensuring Data Integrity and Validation of Computerized Systems.

The manual contains recommendations for pharmaceutical manufacturers on obtaining, storing and integrity of records generated, maintained in working order from their creation to archiving, in order to maintain GMP processes with a guarantee of high quality of manufactured pharmaceutical products.

The manual is also intended for pharmaceutical inspectorates of the states of the Eurasian Economic Union performing pharmaceutical inspections of production sites for compliance with GMP requirements.

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