GAMP 5 - Good Automated Manufacturing Practice M7: Appendix M7 Validation Reporting

What does M7 require?

Where the plan requires it, a computerized system validation report is produced centred on patients, product quality and the integrity of data, summarizes the activities performed, deviations from the plan, outstanding and corrective actions, and says whether the system is fit for the use intended; its level of detail reflects risk, complexity and novelty, its structure mirrors the plan, it is approved as a minimum by the quality unit and the process owner and by other plan approvers such as the system owner as appropriate, and sub-reports or an interim release report may be used for larger systems, with each plan addressed by a corresponding report and, for Agile developments, a report before the initial release and subsequent releases reported as the plan defines. Contents include introduction and scope with differences from the plan, scope changes justified or referenced to a tracking log, a summary of supplier assessment referencing rather than repeating the assessment reports and stating that accountability stays with the regulated company, a summary of activities by reference, verification that all deliverables including tool records and operational procedures are complete and approved, deviations and corrective actions with next steps, a clear statement of fitness for intended use, verification that training and knowledge management are in place, how compliance will be maintained by reference to procedures, a glossary and appendices; the quality unit ensures the report complies with the plan and company procedures, and roles that changed during the project are noted.