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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.
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References

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PDA Journal of Pharmaceutical Science and Technology: 72 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
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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

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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
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  • 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
  • PDF

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  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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Keywords

  • Data integrity
  • Regulations
  • ALCOA
  • Self-Audit
  • Self-Inspection
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  • US FDA
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