Validation Service > Performance Qualification > PQ Documentation

PQ Documentation

Main Process

 

 

 

See also

 

The performance qualification (PQ) ensures that the total system performs as intended in the specified operating range. The total system includes all hardware and software components, associated equipment, people, and procedures that make up the system. The execution process is conducted using company-specific, predefined dataset or actual live data.

 

Performance qualification is not the same as validation. In earlier literature and in the industry, performance qualification was often called validation or validation testing. The two processes should not be confused. Performance qualification is one process in a series of processes, which make up validation.

 

During the development process, a system acceptance test will have been performed, either at the supplier site or at the user site. This system acceptance test forms part of the PQ.

 

The PQ should always be performed at the user site (and may involve repetition of all or part of the system acceptance tests as required) and will include testing specific to the user environment and defined ways of working.


The following business goals and objectives can be achieved through the implementation of these processes:


PQ Protocol

Describes how the PQ should be performed. A PQ protocol should be written and should contain:

 

  • Description of the use of the system in the context of the work environment
  • References to SOPs or other user documentation and the user requirements/functional specification as required
  • Qualification scripts
  • Qualification data
  • Justification for the choice of data
  • Expected results
  • Data set-up requirements
  • Testing procedure
  • Resolution procedure for unexpected results Acceptance criteria for qualification
 
PQ Qualification Scripts

Describes the procedures to verify the performance of the system against the User Requirements Specification. The scripts should simulate the operation of the system in a live situation, using all system components and operating procedures.

 

Scripts may be broken down into multiple steps for ease of use. There should be a direct reference between the test script and the specification against which the testing is being performed.
 
PQ Report

If the PQ generates extensive documentation, then a summary report should be written.

 

This report may be reviewed by the system validation steering team instead of reviewing all the raw data. (Note: You should still retain the raw data.)

 

A knowledgeable and responsible person who reviews all the raw data should write the report.

 

  • The summary report should include this information:
  • Whether or not the qualification scripts were followed
  • Whether or not the expected results were attained
  • Description of any deviation from expected results
  • Any follow-up activities to correct any deviations
  • Statement of whether the performance qualification results meet the acceptance criteria
  • Justification for the acceptance of the validation of the system