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By Donald C. Singer

Publication through Singer, Donald C.

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Sample text

Elements that should be part of the procedure are: • A defined convention for naming files that will result in traceable data files for every sample, including quality control samples and calibration data; • A backup system that can be used to retrieve old data files; • A policy for making changes to electronic data; and • A documentation procedure that will flag every data file that has been manually manipulated, show the changes that have been made, explain the rationale for the changes, and identify the individual making the changes and the date and time the changes were made.

KEY WORDS • GLP • GMP • GLAP • GAMP • LIMS • Software validation • Electronic signatures • Revalidation • Computer systems • Computer system security • Computer system audits • Computer system hardware • LIMS raw data 39 40 Part II: Critical Laboratory Operations INTRODUCTION The good manufacturing practices (GMPs), the good laboratory practices (GLPs), and the good clinical practices (GCPs) were authored to insure safe production of medical devices and pharmaceuticals. The increased use of computerized data collection in the manufacture of medical devices and pharmaceuticals has resulted in new problems with sample and data integrity.

Control of the documents through procedure, training, and uniqueness is required. The FDA “Guide to Inspections of Pharmaceutical Quality Control Laboratories”2 issued in July 1993 has a section covering records and documentation. The guide provides key areas and points which an FDA investigator or a customer auditor could examine equally. The laboratory manager is encouraged to use the guide to ensure that all areas, including documentation, are adequately maintained to meet current regulatory expectations.

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