Biomedical Engineering Reference
In-Depth Information
FIGURE 13.2 Breakdown of an instrument validation work stream. A critical aspect of instrument validation is that it follows the predicate rule,
meaning that the process is governed by a defined set of procedures and exercises. This table represents an example by which a predicated validation could
be executed. The traceability matrix (third row in the table) is a nonobvious tool that facilitates all downstream activities through an auditing function.
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