Modules V and XVI are closely related regulations providing requirements for Risk Minimization Measures (RMMs) that you’ll need to account for in your RMPs. Where Module V covers your routine requirements, Module XVI adds the additional punch—you now need to track not just implementation, but also the effectiveness of your RMP. This can introduce complexity into your RMP strategy, especially given each of the EU member states’ varying requirements for RMM.
Keeping an audit trail, tracking exactly what happened and when, can virtually eliminate the chances of audit findings, and goes a long way towards supporting Module XVI compliance. Unfortunately, most companies are still using spreadsheets and Outlook reminders to track these obligations. In other words, since these organizations are still using manual processes, it is difficult to prove that the RMM tasks were done and done right.
Here’s 5 big things you can do to make auditing, tracking and managing RMM information easy:
Creating one area where all stakeholders can update their own information reduces the work around tracking processes for compliance. Plus, by providing secure but simple access to that centralized information, stakeholders can upload and edit their information themselves.
The first step to tracking your process is ensuring that users remember where and when to submit reports for the RMM. Automated reminders make sure that these materials are submitted on time—without the hassle of reminding your affiliates when Action Responsibilities are due.
It isn’t enough to say a task is done. Managers need authoritative reports proving it has been completed on time. Making sure we know the Single Source of Truth for this information is key to Module XVI compliance.
A pharmacovigilance system should provide quick ways to look into your process, with dashboards and reports, helping you find which areas need the most attention quickly. This way, we can appropriately address oversights, CAPA events and miscommunications before they are ever found by an auditor.
Finally, a validated system will tell you what information has been added and when—vital to proving your company’s Module V and XVI compliance.