Review ArticleReview
Data Integrity: History, Issues, and Remediation of Issues
Anil K. Rattan
PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 105-116; DOI: https://doi.org/10.5731/pdajpst.2017.007765
Anil K. Rattan
Boston Biomedical, Inc., 640 Memorial Drive, Cambridge, MA 02139, USA
Ph.D.
References
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- 2.↵MHRA. GMP Data Integrity Definitions and Guidance for Industry March 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
Data Integrity: History, Issues, and Remediation of Issues
Anil K. Rattan
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 105-116; DOI: 10.5731/pdajpst.2017.007765
Jump to section
- Article
- Abstract
- Introduction
- What Is Data?
- What Is Integrity?
- History of Regulations
- What Is ALCOA?
- Now ALCOA Plus
- What Is the Impact of the Absence of Data Integrity?
- How To Prevent Data Integrity Issues?
- What Is a Breach of Data Integrity?
- What Is Data Integrity Regulatory Impact?
- Simple Checklist and Self-audit Or Self-inspection (SASI) Can Go a Long Way
- Conclusion
- Conflict of Interest Declaration
- Acknowledgement
- References
- Figures & Data
- References
- Info & Metrics
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