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Management of documentation and records is one of the pillars of a quality management system (QMS).

Several chapters of the ISO / IEC 17025 4.2 Management system, Document Control 4.3, 4.13 and 5.4.7 Control of records Control of data are dedicated to thesis topics.

Ce document replaces Guideline PA / PH / OMCL (97) 5 and the share of Guideline PA / PH / OMCL (07) 105 DEF related to the archiving of records.

The purpose of this guideline is to help OMCLs in Establishing and Maintaining procedures:

- To control internal document: generate, identify, approve, issue, review, revise and archive

- To control external documents: access, distribute, Ensure availability and implementation of current versions and track / archive previous versions

- To Identify, collect, index, access, file, store & Maintain and features of quality and technical records in order to guarantee the legibility, durability and traceability of documentation and records.

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EDQM Management of Documents and Records

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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