Has this ever happened to you? You’ve finally reached the end of a validation project. At this point you’ve spent hours planning, testing, resolving non-conformance and issuing documents. Now all that is left to do is write the summary report and you find yourself with writer’s block!
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 Validation Summary Report
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. At a minimum, the VSR should address the following elements:
- Identification of the system subject to validation.
- An inventory of all the deliverables generated during the validation effort including the document identifier and the approval date.
- A summary of the results obtained during testing along with a discussion of any non-conformance encountered, their impact, and how they were resolved.
- Details of any deviations from the Validation Plan and the impact of these occurrences on the validation project.
- A list of any outstanding issues along with any known system limitations.
- A statement of acceptance allowing for the release of the system.
Since the VSR covers a wide variety of topics, it is essential that its contents are detailed in a structured manner. The order in which information is presented should be logical and easy to follow. Use tools, such as tables, to help summarize results and findings.
Consider your regulatory audience
When writing any report, it is important to consider your audience. While the Validation Summary Report will be reviewed and approved by stakeholders within your organization, it is also an auditable record which may be viewed by inspectors or auditors. In general, these individuals are looking for documented evidence that validation activities were performed in accordance with approved procedures. They are also interested in seeing that the system was adequately tested.
As a result, the report should be written so that it is clear and concise. It’s also important to refrain from using vague and ambiguous terms.
TIP 1: Keep in mind that the inspectors/ auditors may not have technical backgrounds and they have not necessarily been involved in validation projects in the past. Avoid specialized jargon and be sure to define all abbreviations. This is especially relevant when summarizing non-conformance and technical issues faced during testing.
TIP 2: The report should also outline the validation approach employed and the measures taken to provide proof of sufficient testing. This approach should be based on the intended use of the system and on the potential risk posed if the system were to not function properly.
Don’t overshare in the VSR
Even though you are generating a comprehensive report, don’t include any unnecessary details. The goal is to provide an overview of the validation effort in the VSR. Don’t forget that this information was captured in depth in the documentation generated over the course of the project. So there is no need to delve into the specifics of every step of the process. Going off on tangents will certainly confuse the inspectors/auditors reviewing the report, making it more likely that they will want to review other validation documents.
In the run-up to audits and regulatory inspections, organizations often scramble to ensure that they are prepared for the inevitable scrutiny of their documents and processes. However, the best preparation for inspections and audits is to ensure that quality standards are respected within the documentation produced on a daily basis.
For validation personnel, this includes ensuring that the contents of Validation Summary Reports are in line with the inspectors’ expectations. Ultimately, considering the auditors’ perspective when drafting summary reports will reassure them that your organization’s validation projects are properly planned and executed, thus reducing the likelihood of observations.