PDA Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories (single user digital version)
- Published
- Aug 2018
- ISBN
- 9781945584053
- Pages
- 63
- PDA Item Number
- 43537
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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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
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Regulatory Trends
- General Considerations for the Control of Data Integrity in the Laboratory
- Data Integrity in the Pharmaceutical Microbiology Laboratory
- Data Integrity in the Analytical Quality Control Laboratory
- Risk Management of Data Governance Systems
- How to Remediate Breaches in Data Integrity
- Conclusion
- References
Figures and Tables Index