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Start Over Topic chromatographic analysis Publisher mjh life sciences
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1. How Complete Are Your Chromatographic Data? Part 2.

Author

McDowall, R. D.

Subjects
*PAPER, *ELECTRONIC records, *INFORMATION retrieval, *QUALITY control, *LABORATORIES, *CHROMATOGRAPHIC analysis
Abstract

The article looks at paper versus electronic records in the context of complete data under the U.S. Food and Drug Administration's (FDA) Good Manufacturing Practice (GMP) regulations for quality control (QC) laboratories in the U.S. It considers whether complete data includes the electronic files generated from a chromatographic analysis or just the signed paper printouts. The requirements for complete data for laboratories working under the FDA GMP regulations are highlighted.

Published
2013