By Donald C. Singer

ISBN-10: 0873894901

ISBN-13: 9780873894906

ISBN-10: 087389491X

ISBN-13: 9780873894913

Booklet by way of Singer, Donald C.

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

Example text

Determine how the software was developed, in-house, contractor, or off-the-shelf. Review the software security. Determine if the system has accurate records, adequate calibration and accuracy, and that the personnel are trained in operation of the system. Determine how the system can be overridden and who has the authority to do that. Review the computer system validation as described previously.

Standard operating procedures (SOPs) 2. Guidelines 3. Policies 4. Protocols 5. Qualification and calibration 6. Calibration records 7. Equipment logbooks 10. Testing methods 11. Laboratory notebooks (LNB) 12. Computer printouts 13. Certificates of analysis 14. Charts 15. Forms 16. Memos 8. Equipment maintenance records 17. Out-of-specification investigations 9. Specifications 18. 1 Change in the types of documents and their content detail. Documentation is only as good as the procedures and training that support it.

Vigilance during operations, and again at the checking stage, is critical to minimize potential problems later. Quality must be built into the entire process of generating data and summaries/discussion documents that ultimately will be reviewed by a regulatory agency during submission reviews, or possibly when performing a site inspection. Chapter Five: Laboratory Documentation and Data REFERENCES 1. Bunn, G. and A. Hart. 1998. “Considerations in Writing Effective Standard Operating Procedures,” Journal of cGMP Compliance (July) 67–74.

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

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