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  2. Process hazard analysis - Wikipedia

    en.wikipedia.org/wiki/Process_Hazard_Analysis

    A simple element of risk quantification is often introduced in the form of a risk matrix, as in preliminary hazard analysis (PreHA). The selection of the methodology to be used depends on a number of factors, including the complexity of the process, the length of time a process has been in operation and if a PHA has been conducted on the ...

  3. 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 ...

  4. 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.

  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. Risk assessment - Wikipedia

    en.wikipedia.org/wiki/Risk_assessment

    Risk assessment determines possible mishaps, their likelihood and consequences, and the tolerances for such events. [1] [2] The results of this process may be expressed in a quantitative or qualitative fashion. Risk assessment is an inherent part of a broader risk management strategy to help reduce any potential risk-related consequences. [1] [3]

  7. 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.

  8. Continued process verification - Wikipedia

    en.wikipedia.org/wiki/Continued_process_verification

    Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report [ 1 ] outlining best practices regarding business process validation in the pharmaceutical ...

  9. ISO 13849 - Wikipedia

    en.wikipedia.org/wiki/ISO_13849

    Figure A.1 cannot be used for risk assessment. Examples of a risk matrix and a risk decision tree are given in ISO/TR 14121-2. [9] Risk assessment is typically done in at least two cycles, the first to determine the intrinsic risk, and the second to determine the risk reduction achieved by the control measures implemented in the design.

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