Annex 11 Articles

June 3, 2011

To help you get up to speed with the ins and outs of the amended version of Annex 11, which will come into effect on 30 June 2011, PTE brings you two articles that take a close look at the amendments.

To help you get up to speed with the ins and outs of the amended version of Annex 11, which will come into effect on 30 June 2011, PTE brings you two articles that take a close look at the amendments.

New Annex 11: Enabling innovation by Markus Roemer

The new Annex 11 offers the opportunity for improvement and innovation. The revisions cover the current hot topics of IT compliance management and are based in the reality of today's systems, organisational structures, IT infrastructure and applications used in the GMP world. At the beginning of the Annex, the 'Principle' section states that: "The application should be validated; IT infrastructure should be qualified." This significant addition is a new clause on IT management in general, which is very much in line with related ISPE good practice guides.

Read the full article for free:http://pharmtech.findpharma.com/Roemer

Annex 11: Progress in EU computer system guidelines by Orlando Lopez

Compared with the older version, the amended Annex 11 contains more details, but remains a concise document that still provides practical and precise specifications that can help ensure that computer systems are produced under a quality system.

Lopez examines Annex 11's Main Directive, Principle and four main clauses: Risk Management, Requirements Management, E-records Management and Validation.

Read the full article for free:http://pharmtech.findpharma.com/Lopez