By Donald C. Singer

ISBN-10: 0873894901

ISBN-13: 9780873894906

ISBN-10: 087389491X

ISBN-13: 9780873894913

E-book via Singer, Donald C.

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Otherwise there may be no other record that a chart exists. It may be difficult to track the correct chart to a project when multiple analyses are being performed simultaneously. Wherever possible the documents should have the cross-reference number entered before the document is printed to avoid the possibility of mixing the results with another analysis. Use of thermal paper has decreased with the advent of newer printers, but if used this paper will generally fade with time. If there is any doubt concerning the ability of the paper to retain the data it should be photocopied and attach to the printout.

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). , are reliable and compliant. Two types of system audits are internal and external audits. Internal audits assure compliance and data validity. External audits are performed to ensure that vendors and suppliers using computerized systems meet the GALP requirements.

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. 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.

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


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