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  2. 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

  3. 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 ...

  4. Title 21 CFR Part 11 - Wikipedia

    en.wikipedia.org/wiki/Title_21_CFR_Part_11

    This guidance supersedes the guidance of the same name dated April 1999; and supplements the guidance for industry on Part 11, Electronic Records; Electronic Signatures — Scope and Application and the Agency's international harmonization efforts when applying these guidances to source data generated at clinical study sites.

  5. Adoption of electronic medical records in U.S. hospitals

    en.wikipedia.org/wiki/Adoption_of_Electronic...

    EMR implementation experiences among hospitals and healthcare delivery systems vary. Some systems have successful experiences, while others do not have as seamless of a transition. For example, in 2002, Cedars-Sinai Medical Center in Los Angeles, CA attempted to implement a new EMR system, but the US$34 million system failed due to numerous ...

  6. Validation (drug manufacture) - Wikipedia

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

    As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system." The subsequent validation or verification of computer systems targets only the "GxP critical" requirements of computer systems. Evidence (e.g. screen ...

  7. Health information technology - Wikipedia

    en.wikipedia.org/wiki/Health_information_technology

    Health information technology (HIT) is "the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, health data, and knowledge for communication and decision making". [8]

  8. Validation master plan - Wikipedia

    en.wikipedia.org/wiki/Validation_master_plan

    A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...

  9. Clinical data management - Wikipedia

    en.wikipedia.org/wiki/Clinical_data_management

    The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure