TABLE OF CONTENTS The validation summary report brings together all of the documentation collected throughout the whole of the life cycle and presents a recommendation for management approval when the system is validated. The document should also contain a formal release statement to allow the system to be used for regulated work.
Section31:
Inspectors should review the firm s Validation Summary Report*, (VSR) for the selected system and refer as necessary to the System Acceptance Test Specification and lower level documents. They should look for evidence that the qualification testing has been linked with the relevant specification s acceptance criteria, viz:
PQ versus URS
Supplier audit reports
Validation plans
*VSR=A best practice high level report, summarising the validation exercise, results and conclusions, linking via cross referencing to lower level project records, detailed reports and protocols. This is useful for briefing both senior managers, in regulated user organisations and for reference by auditors/inspectors.
Section 5.2.6: User Site Testing29:
User site testing should follow a pre-defined written plan with a formal summary of testing and a record of formal acceptance.
Section 6.2: Defined User Requirements29:
The device manufacturer should have documentation including: defined user requirements; validation protocol used; acceptance criteria; test cases and results; and a validation summary that objectively confirms that the software is validated for its intended use.
The aim of the validation report is a summary document not a full-length novel of Nobel Prize...
