Regulatory library

FDA guidance: Data Integrity and Compliance With Drug CGMP: Questions and Answers

FDA's 2018 questions and answers on data integrity. It explains what CGMP expects of data that equipment and computerized systems create: attributable, complete and reviewed records with audit trails that are not switched off.

ValDoc's library holds 1 provision of FDA guidance: Data Integrity and Compliance With Drug CGMP: Questions and Answers. This page is guidance in our words. The regulation's own text governs.

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Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. FDA guidance: Data Integrity and Compliance With Drug CGMP: Questions and Answers, Questions 1–18

    Effective DEC2018

    Data Integrity and Compliance With Drug CGMP: Questions and Answers

    Open the FDA site

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Thirty minutes. Bring one piece of equipment.