Data Integrity—A Study of Current Regulatory Thinking and Action

Nader Shafiei; Regis De Montardy; Edwin Rivera-Martinez

doi:10.5731/pdajpst.2015.01082

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Data Integrity—A Study of Current Regulatory Thinking and Action

Nader Shafiei, Regis De Montardy and Edwin Rivera-Martinez

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 762-770; DOI: https://doi.org/10.5731/pdajpst.2015.01082

Nader Shafiei

1Sanofi Global Quality Strategy & Systems, Bridgewater, NJ;

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For correspondence: Nader.Shafiei@sanofi.com

Regis De Montardy

2Sanofi Global Quality Strategy & Systems, Croix de Berny, France; and

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Edwin Rivera-Martinez

3Sanofi Global Quality Audit, Bridgewater, NJ

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vol. 69 no. 6 762-770

DOI

https://doi.org/10.5731/pdajpst.2015.01082

PubMed

26659106

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 10, 2015.

Author Information

Nader Shafiei1,*,
Regis De Montardy2 and
Edwin Rivera-Martinez3

¹Sanofi Global Quality Strategy & Systems, Bridgewater, NJ;
²Sanofi Global Quality Strategy & Systems, Croix de Berny, France; and
³Sanofi Global Quality Audit, Bridgewater, NJ

↵*Corresponding author: 55 Corporate Drive, Bridgewater, NJ 08822, Nader.Shafiei{at}sanofi.com

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Data Integrity—A Study of Current Regulatory Thinking and Action

Nader Shafiei, Regis De Montardy, Edwin Rivera-Martinez

PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 762-770; DOI: 10.5731/pdajpst.2015.01082

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Data Integrity—A Study of Current Regulatory Thinking and Action

Nader Shafiei, Regis De Montardy, Edwin Rivera-Martinez

PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 762-770; DOI: 10.5731/pdajpst.2015.01082

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Keywords

Data integrity
Regulatory action
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Human errors
Noncompliance

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