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    21 CFR Part 11 and QMS Software Risk-Based Implementation

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    Website https://www.complianceonline.com/21-cfr-part-11-qms-software-risk-based-implementation-webinar-train | Edit Freely

    Category

    Deadline: December 06, 2020 | Date: December 16, 2020

    Venue/Country: U.S.A

    Updated: 2020-05-21 00:21:13 (GMT+9)

    Call For Papers - CFP

    CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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