This Technical Report, developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, provides the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the laboratory. It is intended to outline regulatory requirements and expectations, along with best industry practices, to ensure data integrity, to highlight common gaps in laboratory data management practices, and to recommend methods of remediation.

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Format: PDF (1 file 2.62 MB)

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Table of Contents:

1. Introduction
2. Glossary of Terms
3. Regulatory Trends
4. General Considerations for the Control of Data Integrity in the Laboratory
5. Data Integrity in the Pharmaceutical Microbiology Laboratory
6. Data Integrity in the Analytical Quality Control Laboratory
7. Risk Management of Data Governance Systems
8. How to Remediate Breaches in Data Integrity
9. Conclusion
10. References

Figures and Tables Index