Annex 11 Articles

News
Article

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

Recent Videos
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology
Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology
Related Content