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  2. Computerized system validation - Wikipedia

    en.wikipedia.org/wiki/Computerized_system_validation

    The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules. Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated ...

  3. Validation (drug manufacture) - Wikipedia

    en.wikipedia.org/wiki/Validation_(drug_manufacture)

    Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. [ 8 ] Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). [ 9 ]

  4. Title 21 CFR Part 11 - Wikipedia

    en.wikipedia.org/wiki/Title_21_CFR_Part_11

    But, as with all FDA guidances, it was not intended to convey the full force of law—rather, it expressed the FDA's "current thinking" on Part 11 compliance. Many within the industry, while pleased with the more limited scope defined in the guidance, complained that, in some areas, the 2003 guidance contradicted requirements in the 1997 Final ...

  5. Electronic common technical document - Wikipedia

    en.wikipedia.org/wiki/Electronic_Common...

    However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [5] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary. [6]

  6. Good automated manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_Automated...

    The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2] Other publications in the GAMP series include: GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems

  7. FIPS 140 - Wikipedia

    en.wikipedia.org/wiki/FIPS_140

    FIPS 140-3 was approved on March 22, 2019 as the successor to FIPS 140-2 and became effective on September 22, 2019. [2] FIPS 140-3 testing began on September 22, 2020, and a small number of validation certificates have been issued.

  8. Validation and verification (medical devices) - Wikipedia

    en.wikipedia.org/wiki/Validation_and...

    For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly ...

  9. Validation master plan - Wikipedia

    en.wikipedia.org/wiki/Validation_master_plan

    The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...

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