Document management software enables investigators to present the information used to reach conclusions clearly and concisely and it helps reviewers to track and approve investigations. Where document management software falls short is in helping to identify what information is needed and how to analyze it. Too often organizations put a new document management system in place to improve investigations, only to find that little has changed.
Investigations are a team effort. Investigators work with subject matter experts (SMEs) such as operators, analysts, and engineers, to gather and sort information. Ideally, the investigators know what questions they need to ask and the SMEs provide that data or help develop a plan to gather it. The investigators then organize and analyze that information to reach their conclusions. Ideally, the investigators wait until they have reached supportable conclusions before documenting their findings. Finally, reviewers read and approve the investigation or send it back for more work. When investigations pass through this process and fail to satisfy auditors or the agency, what went wrong?
As much as it suggests progress, implementing investigation software, is not enough to improve investigations. In our experience, many difficulties begin with the issue identification and escalation process. Not all deviations require the same approach to resolution and, too often, people are not in agreement about how to classify different issues and determine an appropriate approach to resolution. Will a note to batch record be sufficient? Perhaps, no investigation is required, but QA will trend the issue to see if it reoccurs. If it is a relatively simple issue, perhaps a “simple” investigation is all that is needed, with an expectation that it be closed within 5 days. Then there are the “complex” investigations that need 20 to 30 days to close and, occasionally, an extension. When organizations have a well-functioning investigation process, where everyone involved in investigations shares a common understanding of how to categorize and conduct investigations, simple and complex deviations are handled appropriately, maximizing compliance and minimizing strain on resources.
Once investigations are categorized, what information is required to complete each category of investigation? Document management software often comes with a large number of standard fields. Different investigators and different reviewers have different understandings of how to populate the fields. In organizations with an effective investigation process, everyone involved in investigations has a common understanding of what information needs to be presented for each category of investigation and in which fields. Reviewers take less time to find the information they need to approve, and investigators spend less time rewriting their investigations, again minimizing strain on resources.
Software solutions greatly increase efficiencies. But a robust underlying process is required for effectiveness. When both work in harmony, organizations can meet regulatory needs, identify opportunities for improvement, and minimize the impact of investigations.
About Kepner-Tregoe
For more than 25 years, Kepner-Tregoe (KT) has collaborated with Pharmaceutical, Medical Device, Biotechnology and Generic clients around the globe to achieve and sustain measures that define exceptional operational performance. In partnership with our clients, the application of our proven tools and techniques have contributed to significant performance improvement in Manufacturing, Quality and Regulatory Compliance. KT customized solutions have produced major improvements in equipment reliability, shutdown and changeover performance. In addition we have extensive experience in troubleshooting, root cause analysis, investigations, CAPA remediation and Complaint Handling.