5 Essential Features in an RMS

Regulatory management software has a number of standard capabilities and features. But not all have everything needed for life sciences companies. So we're outlining the features you absolutely need to know are in the RMS you select. ?

1. Centralized Platform?

A centralized platform enables you to store your data in an organized manner. It allows your employees to view the different lifecycle phases of a product easily – all employees who need to know this data. It also provides an integrated archive of all applications, dossiers, and health agency communications related to a product.?

2. A Business Solution?

An RMS needs to cater to businesses of all sizes, not just big pharma or startups. An RMS should support multiple product types, divisions, sub-groups, and manufacturing sites worldwide. It must be a tool that can adapt to any country, regulation, or SOP (standard operating procedure).??

It also needs to be easy to use because it becomes your daily workspace. And because it’s your workspace, it needs features like tracking, commenting, creating to-do lists, and notifications. With an RMS, you can get rid of paper, pencils, and pesky excel spreadsheets.?

3. Time Management?

Time management is vital for two reasons. First, having everything centralized gives you one place for all information, saving you time. Time you would have otherwise spent going from place to place to collect the data and information and then time to put it all together.?

Second, an RMS allows you to set up a dispatch date, sub-dates, and approval dates and has the reporting to help you measure planned versus actual dates around activities. This is important when you are the head of the department because you can now discuss why the planned date is different from the actual, route issues to the right area, and figure out how to remedy the problems.?

4. Adherence to FDA Directive 21 CFR Part 11?

Along with all the regulations and directives around drugs and medical devices, the FDA also applies directives to computerized systems – particularly in the Pharma industry.?21 CFR Part 11?and?EudraLex, Vol 4, Annex 11?– issued by the FDA and EU, respectively, define criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records. Each provides a set of guidelines that software for pharma must follow. So always ask and be sure the software you select adheres to these guidelines.?

5. Analyze Data in More Than One Dimension?

The final feature is critical for a regulatory management system – data analysis. You want an RMS that lets you extract any information you want in any format you want. Built-in reporting is also crucial. You need to be able to track and manage obligations, including seeing compliance gaps.

Learn more about these five essential features on the website.

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