Although you never know when one might happen, preparing for FDA inspections is necessary for all clinical research sites. Early and comprehensive preparation for an inevitable inspection is perhaps the best predictor of a successful audit. The best way to prepare for an audit is to transition your paper-based systems to digital. Sites that shift to digital solutions for regulatory management are at a distinct advantage when FDA inspections arise because all regulatory tracking materials are already documented in the system. As a result, your staff can focus their efforts on patient care and trial management knowing they are ready for an FDA inspector at any time.
In digital regulatory systems, binders are replaced with an easy-to-navigate resource accessible by any computer connected to the site system. No time is wasted hunting for the right information or traveling to a far-flung corner of a site where regulatory information is stored. Crucial information is right at the staff’s fingertips. This makes regulatory management and FDA inspection preparation easier, more efficient and more accurate.
There are some key considerations and steps to consider when making the transition to digital regulatory systems, specifically when considering how that change will affect staff preparation for and participation in FDA inspections.
- Document the current procedures and time allotted to FDA inspection preparation by your team. What are your site’s SOPs and how will they change when digital regulatory management is put in place? You will likely need to revise your operations process and clearly document expectations now that staff can access regulatory information securely and in real time. Team training will be critical as will communicating to staff that digital files allow them to work more efficiently. With regulatory data in an easy to access digital form, your team won’t have to spend precious time organizing binders or decoding paper management systems for FDA inspectors.
- Consider differences between paper-based and digital regulatory management for when FDA inspections happen. You likely provided inspectors with binders for review that needed intense staff time to help manage, provide further information, and clarify manual notes within the files. With the transition to eReg, FDA inspectors will have direct access to your system. This makes the selection of a eRegulatory partner with deep experience in navigating inspections and audits crucial. Leverage eReg experts to define FDA requirements that can be built into your transition early to avoid challenges when inspectors arrive on site.
- Preparing for FDA inspections are certainly made easier and more efficient with the transition to digital regulatory management. However, reevaluating your processes and eReg configuration after the first FDA inspection using digital documentation is also a critical step. How much staff time was saved? Was that savings reallocated to revenue-producing activities and, if not, how can you better manage that now that you know the actual benefits in savings? Were the inspectors able to easily review necessary materials; are there any improvements for data input you need to enact for future FDA visits? Holding a lessons learned session with both your internal experts and your eReg partner will help with continuous improvement not only for inspections, but for your site’s ongoing regulatory management.
Check out our latest guide “Five Steps for Digitizing Regulatory Management” to help you better prepare for future FDA inspections. If you need help selecting the right system and transitioning your work processes, request a demo of our powerful eReg or other eClinical solutions.