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European Pharmaceutical Contractor

Why, When and How to Implement Electronic Data Capture - Core Decision Points

European pharmaceutical companies wishing to supply the US market are regulated by the US Food and Drug Administration (FDA). There has been a 10-year dialogue between the FDA and global drug manufacturers about the acceptance of and mechanisms for implementing validated electronic signatures to replace manual sign-off throughout the drug development and manufacturing process. This article reflects on the practical impact on European pharmaceutical companies of the regulation finally agreed between the FDA and the industry, affectionately known to all as 21 CFR Part 11.

Modern LIMS to Help Support 21 CFR Part 11

In the early 1990s, members of the pharmaceutical industry met with the US Department of Health and Human Services and the Food and Drug Association (FDA) to determine how a paperless record system could be accommodated under the current Good Manufacturing Practice (GMP) regulations. In March 1997, after a six-year iterative development process with the industry, the FDA issued the final rule. Following a five-month grace period, the rule became effective on 20th August 1997.

The rule sets forth the criteria under which the FDA considers electronic records and electronic signatures to be equivalent to paper records and handwritten signatures. The rule is an extension to the predicate rules for GXPs - GLP: 21 CFR 58 for laboratories; GMP: 21 CFR 211 for manufacturing; 21 CFR 820 for medical devices; and GCP: 21 CFR 320 for clinical environments. 21 CFR Part 11, the FDA's final rule on using electronic records and electronic signatures, affects all pharmaceutical companies in Europe that sell products in the US. Even for those who do not sell within the US now, this regulation is still very important because in the near future all regulatory authorities will be working according to a similar standard.


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By Peter Boogaard, European Applications Manager at Applied Biosystems

Peter Boogaard has been involved in the field of laboratory automation since the introduction of commercial LIMS systems in 1981. Additionally, his career path has included several positions within database companies, including Oracle and Informix Corp. He has been Product Manager for the Informatics LIMS business unit in the US.

Peter has held several positions within the European Informatics organisation, including marketing, new business development and manager professional services. Peter Boogaard's current responsibility is managing the European Applied Biosystems Marketing Intelligence group in the Netherlands.

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