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November 2011

Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

by Orlando Lopez
Independent Consultant

The two (2) essential resources available to regulated life-science professionals regarding the validation of computer systems are: the United State's Food and Drugs Administration's (US FDA) rule on Electronic Records/Signatures (21 CFR Part 11 a.k.a. Part 11) and the EMEA's Guidelines to Good Manufacturing Practice (GMP) - Annex 11, Computerized Systems (a.k.a. EU Annex 11).

Part 11 establishes the requirements for the technical and procedural controls that must be met by the regulated user if the regulated user chooses to maintain regulated records electronically. Part 11 was published in March 1997. It is strictly applicable in the US to all FDA program areas. Part 11 is applicable also to manufacturers outside of the US and its territories who wish to gain US FDA market approval. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. For the purpose of this analysis it is required to consider the Part 11 Guideline (2003). This guidance is the one used by the FDA for interpretation and to enforce the Part 11 requirements established in the Part 11 regulation. (See Analysis of Part 11).

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Jason Clegg

Change Control - Continuous Quality Improvement in FDA and ISO Environments

by Jason Clegg
Marketing Director

Globalization of the marketplace has greatly intensified competition and has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.

The situation could not be more acute than in the FDA and ISO environments, where manufacturers must contend not only with cutthroat competition and a dynamic market, but also stringent regulatory requirements. Consider the fiercely competitive pharmaceutical industry. Only one of every 10,000 potential medicines investigated by American research-based pharmaceutical companies survives the rigorous FDA approval process, according to the Pharmaceutical Research and Manufacturers of America. It takes about 15 years at a cost of more than $800 million before a new medicine is approved.

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"It seems a rather uncontroversial proposition: FDA-regulated companies are responsible for their vendors, including every contracted piece of work that is done on the company’s behalf. If problems develop, it makes no difference whether a company did it…or a contractor did it for them. Two seemingly unrelated items this week suggest that FDA is becoming concerned about whether FDA-regulated companies are overseeing their vendors."
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