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  2. Verification and validation - Wikipedia

    en.wikipedia.org/wiki/Verification_and_validation

    Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.

  3. SCVP - Wikipedia

    en.wikipedia.org/wiki/SCVP

    The Server-based Certificate Validation Protocol (SCVP) is an Internet protocol for determining the path between an X.509 digital certificate and a trusted root (Delegated Path Discovery) and the validation of that path (Delegated Path Validation) according to a particular validation policy.

  4. Validation (drug manufacture) - Wikipedia

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

    The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols.

  5. 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 ...

  6. Data validation - Wikipedia

    en.wikipedia.org/wiki/Data_validation

    Data validation is intended to provide certain well-defined guarantees for fitness and consistency of data in an application or automated system. Data validation rules can be defined and designed using various methodologies, and be deployed in various contexts. [1]

  7. Process validation - Wikipedia

    en.wikipedia.org/wiki/Process_Validation

    Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]

  8. Process performance qualification protocol - Wikipedia

    en.wikipedia.org/wiki/Process_Performance...

    Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.

  9. Computerized system validation - Wikipedia

    en.wikipedia.org/wiki/Computerized_system_validation

    The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting. The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules.

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