Regulatory compliance is complex and time-consuming for life sciences organizations. But there are ways to make it easier with the assistance of technology. In a recent webinar, MarieLouise Abi Hanna, RMS Product Lead, provided insights and guidance on regulatory management systems (RMS) and how they help pharmaceutical, medical device, and biotech companies build and maintain effective and efficient compliance processes. This is part one of a summary of that webinar. You can watch the full webinar on-demand here.
What is regulatory compliance?
Regulatory compliance ensures your company complies with the laws and regulations that apply to your industry, protecting your company and your patients and customers. It’s essential to running a successful business in pharma and healthcare.
While you can perform compliance activities through manual and paper processes, a regulatory management system ensures that nothing falls through the cracks by managing all your regulatory requirements and responsibilities.
“As we know, healthcare organizations are subject to a wide range of regulations for drugs, medical devices, or supplements. So, any non-compliance with these regulations can result in significant safety concerns for the patient, in penalties for the organization, as well as the damage to an organization’s reputation.”
The Key Capabilities of a Regulatory Management System
A regulatory management system – or RMS – serves as a central repository for all information in your organization. Marielouise said she had seen many tools used to manage regulatory documents, but most were disconnected tools scattered across the organization. For example, some people used spreadsheets; some used SharePoint, and others stored documents on their desktops.
“Having a central database – a one-stop shop – for everything you need for regulatory information is critical.”
One of the key elements of an RMS is compliance, which Marielouise continually came back to in her talk, as it is the basis of everything an RMS does.
As a central repository, an RMS provides the following:
- A single location to store all information
- Access to all users
- Compliance for all users
- Compliance with regulations
It also tracks commitments of health agencies, such as deadlines for inquiries, submissions, and clock stops. Reporting is another critical capability for an RMS because it helps you understand what to do with all the data in your system.
Marielouise made an important note here, saying that an RMS is not only a central repository for the regulatory department but the entire organization. It can provide read access to everyone who needs to see the information – quality assurance, supply chain, medical department, marketing, sales, and pharmacovigilance (even if it uses a third-party provider).
It’s also not only a central repository but includes features and functionality that help you manage all your regulatory processes.
So, let’s look at the main capabilities of what Marielouise calls an “effective RMS.”
Built-in Submission Planner
The first thing you should look for in an RMS, said Marielouise, is a built-in submission planner and tracker. Too often, individuals are tracking things in spreadsheets or on their desktops. The problem is that it is very individualized and not well maintained. Even if a manager and a supervisor manage information in this way, there’s still no visibility to the rest of the organization unless they call or email a request (and then there is often disagreement).
An RMS with a submission planner and tracker ensures everyone has access to information, such as when submissions are expected or planned or when a dispatch is planned.
Product Registration Management
The moment a record is created in the RMS, a product registry is issued and enables you to track every about that product registration and lifecycle, including change controls, renewals, pricing reviews and health agency inquiries.
Product Data Management
Registration leads to product data management. You don’t want one database to store dates and information and another to hold the archive. An RMS enables you to store product data, the complete dossiers, communications and regulations – all in a single location.
Product Lifecycle Management
Regulatory professionals know that a product doesn’t end at registration. That’s where it starts. When a product receives market authorization, you are automatically required to manage the lifecycle of that product as long as it’s on the market and sometimes even after it’s discontinued. From a compliance perspective, you need to maintain data in your system for future audits or to preserve the history of the product, depending on your SOP processes).
Product lifecycle management includes all change controls issued by quality assurance or the medical department, depending on the type of change or variation issues, renewals, pricing, and health agencies deficiency letters.
Notifications and Alerts
A key advantage of an RMS over spreadsheets or paper-based processes is the ability to get notifications and alerts related to deadlines. Your SOPs will define the notifications and alerts you need to set up in the RMS and how they are sent (email, in-app, etc.).
An RMS is an interactive tool designed to keep regulatory professionals ahead of deadlines or other actions. For example, it will notify you when you need to perform a dispatch or prepare a dossier to send to your representative in your export country.
Dashboards are also nice with visuals and charts that you can use in management presentations. Dashboards give you a visual perspective on things such as open actions, approvals, and other activities happening in the RMS.
Reporting in an RMS was a headache when it wouldn’t allow Marielouise to export those reports for external use. She often had to copy the data manually or build the reports in Excel. But you need this capability built into your regulatory management system. It takes a lot of discipline and commitment to add your product information to an RMS, keep it updated and ensure it’s accurate. And you’re doing it for the entire organization. A reporting tool that allows you to export this data efficiently is critical, whether for monthly reports such as tracking submissions, open changes, renewals, or pricing or specific reports such as a specific change that may have triggered a regulatory submission in some countries.
Note: Keep Your Publishing Capability Separate
A question was asked during the webinar about publishing capabilities within the RMS. Marielouise said it could be part of your RMS or a separate but associated tool. She recommended keeping it separate because health agencies are trying to upgrade their systems into digital submissions in emerging markets. There are often different versions of how these submissions are made. Therefore, an RMS may not be able to support all versions.
Instead, she recommends preparing a dossier in CTD format in the RMS that is then downloaded and imported into a publishing system. That way, you can adapt to each health agency’s requirements.
Look for the Right RMS for Your Organization
Not all regulatory management systems provide the capabilities described above, but they should. When you have determined that it’s time to update and digitalize your processes, you’ll want to look for an RMS that offers all these capabilities. Make sure you have a list of questions to ask the vendor from a technical perspective and a list of requirements matching your processes.
Next, we’ll tell you about five features you absolutely need to have in your RMS. Until then, you can watch the webinar on-demand to hear more about regulatory management systems.