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| home > epc > spring 2003 > the other side of 21 cfr part 11: there is more to it than technology |
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European Pharmaceutical Contractor
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August 2002 marked the fifth anniversary of the implementation of the FDA's 21 CFR Part 11, Electronic Records; Electronic Signatures Rule (Part 11, ERES Rule, The Rule). The passing of time has done little to quell the debate on the interpretation of the Rule and the means of achieving compliance. Even as systems tailored to Part 11 are being introduced, there is still no industry-wide consensus on the subject. Consequently, the compliance plans range from reverting to stone tablets to starting over by replacing everything with brand new systems.
Part 11 and the Predicate Rules
Human pharmaceuticals and biologics R&D in the US is governed by a number of FDA regulations. Among them are the predicate rules and 21 CFR Part 11. The former include good laboratory practice (GLP), good manufacturing practice (GMP) and good clinical practice (GCP), collectively referred to as GxP. These rules set forth requirements for ensuring the safety and effectiveness of the marketed products and are standalone regulations. Part 11 on the other hand, addresses only electronic signatures and records that are covered by all predicate rules, therefore making it an add-on document. In a sense, it provides a means of ensuring that regulations keep pace with technology.
When considering compliance with 21 CFR Part 11, it must be emphasised that this regulation does not mandate the use of electronic systems or signatures; rather it sets rules and constraints around their use under the predicate rules. Thus, by virtue of the fact that the records and signatures are generated in the process of proving the safety and effectiveness of the products, the predicate rules provide the overall basis for building Part 11 compliance. It is quite likely that the debate about Part 11 compliance continues to rage because many of the stakeholders do not recognise this connection.
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