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Research ArticlePDA Paper

PDA Points To Consider: Fundamental Concepts in Data Integrity

Bob Buhlmann, Madlene Dole and Zena Kaufmann
PDA Journal of Pharmaceutical Science and Technology September 2016, 70 (5) 482-488; DOI: https://doi.org/10.5731/pdajpst.2016.007062
Bob Buhlmann
1Director, Corporate Quality Assurance, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA;
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  • For correspondence: buhlmann@amgen.com
Madlene Dole
2DI Program Lead and Head of Strategic Planning and Operations Group QA, Novartis; and
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Zena Kaufmann
3Consultant, ZGK Consulting
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Article Information

vol. 70 no. 5 482-488
DOI 
https://doi.org/10.5731/pdajpst.2016.007062
PubMed 
27436430

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 3, 2016.

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  • previous version (July 19, 2016 - 11:25).
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© PDA, Inc. 2016

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PDA Journal of Pharmaceutical Science and Technology: 70 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 5
September/October 2016
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PDA Points To Consider: Fundamental Concepts in Data Integrity
Bob Buhlmann, Madlene Dole, Zena Kaufmann
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 482-488; DOI: 10.5731/pdajpst.2016.007062

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PDA Points To Consider: Fundamental Concepts in Data Integrity
Bob Buhlmann, Madlene Dole, Zena Kaufmann
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 482-488; DOI: 10.5731/pdajpst.2016.007062
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  • Article
    • Executive Summary
    • Purpose
    • The Importance of Data Integrity throughout the Product Lifecycle
    • Current Regulatory Trends and Recent Issues in Data Integrity
    • Data Management Systems Considerations
    • Globalization and Cultural Factors
    • Elements of Data Integrity
    • Holistic Approach to a Data Integrity Program through the Data Lifecycle
    • Conclusion
    • Conflict of Interest Statement
    • Appendix
    • References
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