Transcription of 別紙（10） PIC/S GMP ガイドライン アネックス11 …
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別紙（10） PIC/S GMP ガイドライン アネックス11 …
1/3 COMPUTERISED SYSTEMS PRINCIPLE The introduction of computerised systems into systems ofmanufacturing, including storage, distribution and qualitycontrol does not alter the need to observe the relevantprinciples given elsewhere in the Guide. Where acomputerised system replaces a manual operation, thereshould be no resultant decrease in product quality orquality assurance. Consideration should be given to therisk of losing aspects of the previous system by reducingthe involvement of operators. PIC/S GMP PERSONNEL 1. It is essential that there is the closest co-operationbetween key personnel and those involved with computersystems. Persons in responsible positions should have theappropriate training for the management and use ofsystems within their field of responsibility which should include ensuring that appropriateexpertise is available and used to provide advice onaspects of design, validation, installation and operation ofcomputerised VALIDATION 2.
2/3 5. The software is a critical component of a computerised system. The user of such software should take all reasonable steps to ensure that it has been produced in
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