T/SHQAP 008-2024 Digital Trace System for Pharmaceutical Production Processes: Technical Requirements for Document Management

Scope

Main technical content: This document focuses on the document management of pharmaceutical production enterprises in Shanghai and proposes technical requirements for digital traceability of the corresponding digital systems (DMS). The content includes all life cycle traceability elements such as document drafting, revision, revocation, approval, effectiveness, distribution, recovery, regular review, archiving, and destruction. The goal is to improve the level of document management and traceability supervision capabilities by establishing digital traceability of document management in pharmaceutical production enterprises. With the widespread application of various business systems in the pharmaceutical production field, the integration of systems, storage backup, communication, and operation and maintenance have also become management priorities, and corresponding traceability requirements have also been proposed for these aspects.

Development Information

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