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

By Donald C. Singer

Publication by means of Singer, Donald C.

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This chapter will review the overall control and generation of documentation in a laboratory and provide suggestions for good documentation practices. Document control must be fully supported by the company through management allocation of adequate resources with time, financing, and people. Implementation of procedures establishing company standards must have the full support of management and be monitored through regular internal audits. Noncompliance relating to documentation identified through audits should be assessed and the root cause(s) corrected, while also determining if any other areas are affected.

Network interface cards and performance data d. Network servers e. Network printers f. Prime server’s power backup VI. Testing Description A. Testing procedures for determining functionality, limits, ranges, etc. 1. Test data 2. Test results 3. Test limit and limits tested 4. Resolve errors 5. Testing conclusions 6. Formal release VII. Documentation A. Standard Operating Procedures B. Validation Documents C. System-related Documentation D. Testing Documentation VIII. Validation Report A. List all required SOPs for LIMSs B.

Validation Documents C. 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).

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