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European Pharmaceutical Contractor

Industry Trends in the Development and Provision of 21 CFR Part 11-Compatible Equipment

Background

The FDA's 21 CFR Part 11 has been in effect since August 1997. Part 11 establishes the standards for ensuring electronic records and electronic signatures are as trustworthy and reliable as paper records and handwritten signatures. The regulation 'applies to records in electronic form that are created,

modified, archived, retrieved or transmitted under any records requirements' (1) as set forth by a predicate rule. Predicate rules include any requirements set forth by any FDA regulation, such as good laboratory practice (GLP), good manufacturing practice (GMP) and good clinical practice (GCP).

In the years following the introduction of Part 11, as industry began to attempt to comply with its requirements, the implications and broad scope of the rule became apparent. Pharma companies were expected to be making progress towards compliance with Part 11 by:
Assessing their current systems against the requirements
Determining the actions needed for each system to attain compliance
Developing procedural and technical controls
Generating and executing validation and implementation plans


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By Lynda Bruce, Principal Engineer in the Life Sciences Business Unit and Annie Broadhurst, Technical Scholar at Cambridge Consultants Ltd

Dr Lynda Bruce is a Principal Engineer in the Life Sciences Business Unit at Cambridge Consultants Ltd where she specialises in regulatory issues affecting process and product development. Lynda joined CCL from Integral Inc, a management consulting firm, where she focused on organisational and strategy issues for clients in the pharmaceutical industry. She has also worked for Wardrop Engineering as a Process Engineer and for Hemosol Inc as a Process Development Engineer.

Annie Broadhurst is a Technical Scholar at Cambridge Consultants Ltd. She also studies Pharmacology at the University of Manchester.

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Dr Lynda Bruce
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Annie Broadhurst
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