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    Criteria for validating assessment tools

    The execution of this VRA not only defines and documents the scope of your validation activity; it also prompts you into documenting how each Part 11 record is evaluated and how it will be managed.This brings you into compliance with the mandate in the latest Part 11 clarification documentation.A properly designed and precisely executed Validation Risk Assessment (VRA) analysis has proved over and over again to be key to the expedient completion of any FDA, WHO and or EU compliant; risk based validation project.Our latest issue of this VRA document (issue 11) reflects these principles and also incorporates the very latest in regulatory mandates and legislative guidance document comments.Eight papers met the inclusion criteria, describing research on a total of eight ethno-cultural assessment tools/models. While many ethno-cultural assessment tools exist to guide nursing practice, few are informed by research perspectives.

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    Thus, in addition to evaluating the group’s output, instructors may need to find ways to determine how groups functioned and the extent to which individuals contributed to the effort.This is now a mandatory requirement and these justifications form regulatory reviewable documents.This new found freedom to assess records and set justified management of them would appear to mean that the original all embracing approach to all electronic records is to be dropped and the full rigors of part 11 applied only to the data that directly affects product quality, safety, and records (of the product) integrity.We used the Critical Appraisal Skills Programme tools for quality assessment.We applied Torraco's definition and method of an integrative review that aims to create new knowledge and perspectives on a given phenomena.

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