Chrysa Plagiannos reports:
"You may be unsure how to summarize an expansive project or just how much detail to go into when describing the various stages of the validation effort. After all, the importance of this report is not lost on you. You’re well aware that the validation summary report (VSR) is often the first validation document reviewed during audits and regulatory inspections. You also know that if the auditors/[inspectors] are satisfied with the contents of the summary report, they will likely move on without requesting other project documents. Whether you are being inspected by a regulatory body or facing a client audit, your VSR has to be auditor-friendly. The purpose of a Validation Summary Report (VSR) is to provide a concise overview of the entire validation effort and the results obtained. Additionally, the approval of the VSR authorizes the release of the system for operational use. Since the validation activities performed were initially defined in a Validation Plan, the information presented in the VSR should be in alignment with the plan and organized in a similar fashion...[T]he VSR should address the following elements:
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