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.
Comments on the efforts to shift from automation and online data processing technology in clinical trials and office practice in lieu of using paper. Development and innovation of electronic office machine equipments; Accessibility of data and information through electronic document management; Plight of the paperless clinical trails.
Published
2004
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.