Laboratory Medicine

A Laboratory Quality Handbook of Best Practices & Relevant by Donald C. Singer

By Donald C. Singer

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Extra resources for A Laboratory Quality Handbook of Best Practices & Relevant Regulations

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The SOPs must include descriptions of hardware required to make raw data human readable. Procedures for signing, dating, and audit-trail generation of raw data created by I/O devices must be addressed. Some electronic recording devices may not have options for operator name and password. The data generated in this method may need to be printed and then signed by the operator. Examples may be sterilizer logs or stand-alone thermocouple devices. Periodic maintenance of the LIMS hardware should be done on the computer network hardware, including testing and inspection.

System-related Documentation D. Testing Documentation VIII. Validation Report A. List all required SOPs for LIMSs B. List all documentation C. List all archived and updated software and documentation D. List all operator documentation E. Attach all validation protocols F. List all software versions validated G. Summary of test conclusions Chapter Six: Sample Control and LIM Systems 49 ELECTRONIC DATA SYSTEM AUDITS Computer systems are monitored and audited to ensure that they comply with the good automated laboratory practices (GALPs).

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. Nonpharmaceutical laboratories can benefit equally from the guide by adapting the information for their individual laboratories.

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