706585 LOGOSCREEN fd Secure Data Management and FDA-Compliant Measured Data Recording White Paper
■The production of products in the pharmaceutical and food industry as well as related industrial sectors is subject to mandatory record keeping requirements.
■In the past, people used paper-based recorders for recording process data. To protect consumers, the parameter values recorded onpaper were archived for decades to ensure complete proof of production and traceability in the event of deviations.
■The introduction of paperless process recording technology triggered a shift from paper-based to paperless recorders.
■The Food & Drug Administration (FDA) in the USA passed Title 21 CFR Part 11 (Code of Federal Regulations) in 1997 regulating the proper and clearly traceable recording of electronic process data.
■This law defines the requirements for Electronic Records and Electronic Signatures, i.e. the paperless logging of production processes as well as electronic signatures that correspond to a handwritten signature.
■Compliance with the requirements of Title 21 CFR Part 11 now forms the foundation for the global acceptance of products from the pharmaceutical and food industry.
■Section 3 of this white paper provides the user with information on the measures taken to meet the requirements for each section of the legal text.
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White Paper |
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Please see the document for details |
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English Chinese Chinese and English Japanese |
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2013-02-08 |
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00597365 |
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433 KB |
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