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Labcompliance News, November 1999

November 1, 1999

21CFR 11 and Paul Motise: Presentation Highlights and Questions/Answers

Paul Motise from the US FDA recently gave presentations at the IVT Conference "Electronic Records and Signatures" in Washington DC and at the ECA Conference "FDA Requirements for Computers in Analytical Laboratories" in Berlin, Germany. He went over part 11 at a high level. He touched on how industry is reacting to the rule and he talked about the difference between acceptance by the technical folks and the regulatory affairs folks. He covered the education and training efforts that are on-going and FDA's enforcement approach to this rule. He also explained how part 11 is going to be a model for other agencies in the United States and how it is really mainstream stuff in harmony with many other standards around the world. At the end Paul Motise answered questions from the audience and from panel discussion members. This site summarizes the presentations, it quotes highlights from the presentation in Berlin and it transcribes most important questions and answers, for example, on long terrm archiving and retrieval of meta data in chromatography and on using spreadsheets under Part 11.

November 1, 1999

New PDA Report: Validation and Qualification of Computerized Laboratory Data Acquisition Systems

-- was prepared by the PhRMA CSVWG (now the PDA Computer Validation Issues Task Group) and the PDA Computer Related Systems-Laboratory Systems Task Group. The purpose of the Report is to provide guidance to laboratory scientists, technicians and managers responsible for the implementation, testing, control and usage of Laboratory Data Acquisition Systems (LDAS) used within a GMP-, GLP- or GCP-regulated environment. TR 31 specifically addresses computerized LDAS within a regulated environment, but is also applicable to systems considered critical to the operation of a company, department or function, regardless of the system's regulatory impact.
1999; 12 pp; $50 members/$75 nonmembers