Log in

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.


EDQM Management of Documents and Records

a3p-100pxhaut logo


Commit to share
Transmit and progress together
Promoting innovation

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.

More info on video (Versiongb - drapeauitalie )

  group    administrators A3P
& Project Managers

letter   newsletter A3P