If you are in the process of researching and selecting a regulatory management system RMS), it’s essential to understand what the key capabilities are (you can read about these here). But equally important is identifying if the RMS you are looking at includes five essential features. What are those features? Let’s take a look.
1. Centralized Platform
You don’t want a bunch of systems helping you track and manage your compliance obligations. There will be too many places to store things, everyone won’t do it the same way, and things are bound to slip through the cracks.
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.
“The most complete and integrated the business solution is, the better the RMS will fit into your organization and your daily practice. It will make it very easy for you and a fun way to maintain your records.”
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.
We have seen in this industry that missing deadlines can lead to shortages in the market of a drug. We always talk about the regulations behind RMS, but it’s also important to recognize that any regulatory action has a commercial impact. When you are delayed, you are affecting patients because your product is not reaching the patient at the right time. Time management is a critical feature that helps keep this from happening.
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.
One of the key regulations in Annex 11 / Part 11 relates to the security measures for signatures and electronic records that must be in place to ensure they are protected from unauthorized access or tampering. They also apply to records retention, ensuring the information is maintained in a format that is accurate, readable, and readily accessible.
Another guideline – GAMP5 (good automated manufacturing process) – comes from the international society for pharma engineering (ISPE) and provides guidance on the development, operations, and maintenance of computerized systems in the pharma industry. GAMP5 is a risk-based approach to risk assessment, system validation, system documentation, maintenance, and control.
Other guidelines to consider include MHRA: GXP Data Integrity Guidance and Definitions Revision 1: Updated 9 March 2018 and PIC/S GUIDANCE PI 041-1 (Draft 3) 30 November 2018: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments.
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. For example, you’ll want to see the deficiency letters you are constantly receiving, which is extremely important when doing a product or portfolio review because you need to see the deficiency letters that are recurrent or all on the same topic.
Another reason for wanting to analyze the data in different ways is to track KPIs for the team. This data is helpful for HR when discussing remuneration, and it helps manage workload. For example, if one regulatory manager appears to have five submissions in a quarter and another has only one, it would make sense to redistribute the workload so it’s fairer and more efficient.
Final Thoughts
Regulators often view digitization as trustworthy and see you taking compliance seriously. So, keep these five features in mind as you look at regulatory management solutions. And be sure to check out Scigeniq RMS as you go through the selection process.