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  2. 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 ...

  3. 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.

  4. Template:W3C validation/doc - Wikipedia

    en.wikipedia.org/wiki/Template:W3C_validation/doc

    Main page; Contents; Current events; Random article; About Wikipedia; Contact us; Donate; Help; Learn to edit; Community portal; Recent changes; Upload file

  5. 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 ]

  6. First article inspection - Wikipedia

    en.wikipedia.org/wiki/First_article_inspection

    Typically, a supplier performs the FAI and the purchaser reviews the report. The FAI process usually consists of fully testing and inspecting either the first part produced by the new process or a sample from the first batch of parts. First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete.

  7. Process qualification - Wikipedia

    en.wikipedia.org/wiki/Process_Qualification

    Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]

  8. 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.

  9. Fagan inspection - Wikipedia

    en.wikipedia.org/wiki/Fagan_inspection

    The software development process is a typical application of Fagan inspection. As the costs to remedy a defect are up to 10 to 100 times less in the early operations compared to fixing a defect in the maintenance phase, [1] it is essential to find defects as close to the point of insertion as possible.