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Articles by Orlando López

Orlando López

Orlando López is an Independent Consultant with over 25 years of software quality assurance experience and more than 18 years in QA and Compliance in the Food and Drug Administration and EU regulated environments. He is a member of the Pharmaceutical Engineering Editorial Review Board. His special interest is the GMP compliance issues applicable to computer systems. Orlando is the author of 2 books: 21 CFR Part 11 - A Complete Guide to International Compliance, published by Sue Horwood Publishing Limited,; and Computer Infrastructure Qualification for FDA Regulatory Industries published by Davis Healthcare International Publishing, He can be contacted by e-mail at

Requirements for Electronic Records Contained in 21 CFR 211
July 18, 2012

The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.


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