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  2. 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 ]

  3. Epidemiological method - Wikipedia

    en.wikipedia.org/wiki/Epidemiological_method

    Epidemiological (and other observational) studies typically highlight associations between exposures and outcomes, rather than causation. While some consider this a limitation of observational research, epidemiological models of causation (e.g. Bradford Hill criteria) [7] contend that an entire body of evidence is needed before determining if an association is truly causal. [8]

  4. Anticipate, recognize, evaluate, control, and confirm - Wikipedia

    en.wikipedia.org/wiki/Anticipate,_recognize...

    The anticipate, recognize, evaluate, control, and confirm (ARECC) decision-making framework began as recognize, evaluate, and control.In 1994 then-president of the American Industrial Hygiene Association (AIHA) Harry Ettinger added the anticipate step to formally convey the duty and opportunity of the worker protection community to proactively apply its growing body of knowledge and experience ...

  5. 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]

  6. 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.

  7. Validation (drug manufacture) - Wikipedia

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

    Process validation involves a series of activities taking place over the lifecycle of the product and process.". [4] A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient ...

  8. 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 ...

  9. 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 ...