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manual recording and transcription; d) maintained in a manner that ensures the integrity of the data and information; e) include recording system failures 2) A Quality Manual or equivalent document must be created which stipulates the laboratory's quality-related policies, procedures and technical practices. Incase of non-computerized systems, provides conditions which safeguard the accuracy of manual recording and transcription; d) be maintained in a manner that There is also no requirement for Quality Manual. By introducing the risk-based thinking in the standard some reduction in prescriptive requirements and.
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