Purpose:

<?>

Objective:

<?>

Description:

<?>

Entrance Criteria:

<?>

Exit Criteria:

<?>

Process and Procedures:

Tailoring Guidelines:

  • None

Process Verification Record(s)

  • Validation reports
    • Stored By: <?>
  • Validation results
    • Stored By: <?>
  • Validation cross reference matrix
    • Stored By: <?>
  • As-run procedures log
    • Stored By: <?>
  • Operational demonstrations
    • Stored By: <?>
  • Validation deficiency reports
    • Stored By: <?>
  • Validation issues
    • Stored By: <?>
  • Procedure change request
    • Stored By: <?>

Measure(s):

  • Compare actual results to expected results.
    • Maintained By: <?>
    • Submitted By: <?>
    • Frequency of Submission: <?>
  • Based on the established validation criteria, identify products and product components that do not perform suitably in their intended operating environments, or identify problems with methods, criteria, or the environment.
    • Maintained By: <?>
    • Submitted By: <?>
    • Frequency of Submission: <?>
  • Analyze validation data for defects.
    • Maintained By: <?>
    • Submitted By: <?>
    • Frequency of Submission: <?>
  • Record results of the analysis and identify issues.
    • Maintained By: <?>
    • Submitted By: <?>
    • Frequency of Submission: <?>
  • Use validation results to compare actual measurements and performance to the intended use or operational need.
    • Maintained By: <?>
    • Submitted By: <?>
    • Frequency of Submission: <?>
  • Provide information on how defects can be resolved (including validation methods, criteria, and validation environment) and initiate corrective action.
    • Maintained By: <?>
    • Submitted By: <?>
    • Frequency of Submission: <?>

References: