How are you managing your medical devices Regulatory Information?

October 1, 2018 Regulatory Information Management

Depending on Excels/ PLM/ERP?

Is your team still using Excel sheets, or other functional teams tools (such as registration trackers or ERP) to manage your global regulatory Health Authority / Notified Body compliance activities?
Learn why these tools pose either compliance or business risks if you manage your regulatory activities.

When it comes to tracking and managing your regulatory needs, Excel, PLM, and other general-purpose tools (like registration trackers) are readily available and your team already knows how to use them. In addition, as some of the commercial/Finance teams lack the comprehension on Compliance processes and corresponding potential risks, they tend to “suggest” using these “other” tools for Regulatory purposes also As a result, many teams end up using such software (or Excels) to manage their regulatory activities and thereby putting companies, products and ultimately patients at risk

4 Risks in Relying on these Tools/Software to Track & Manage your Regulatory Activities:

1. Inaccurate regulatory information
As these are all general-purpose tools, it is very hard to gather all regulatory information in a structured manner within a stipulated time. This often leads to incomplete information which leads to either overlook by teams or extra efforts to gather information from different sources

2. Improper Requirements & External teams Access
Trackers created using Excel usually are stored on the author’s computer and are not accessible by other teams (locally & globally) in real-time.
This makes it harder to share, validate, and track changes – frequently leading to incorrect requirements which may cause delays in regulatory submissions or answering notified body findings

3. Compliance Risks
Most importantly – it is very easy for regulatory information to fall through the cracks when using Excel/PLM/ERP to manage them. Even critical information can be lost when the resource who is handling these sheets forget to update, or gets reassigned to other projects, or leaves an organization.

4. Technology Burden
If companies create their own in-house systems for this, the tightly coupled integrations and the complexity that comes with it makes the upgrades very challenging when the business requirements change. With cloud based 3rd party tools, this risk is greatly mitigated.

What Should You Do Then?

So what causes such inefficiencies? The primary culprit is disconnected systems and data. According to a recent Regulatory Information Management (RIM) report from a leading research firm, a majority of organizations have a fragmented technology landscape with disparate tools and systems for identical-and related tasks. By recognizing the inherent problems using siloed systems, 2015 study reports that a growing number of companies are starting to employ global models.

A modern RIM tool that promotes global & external access, data harmonization and standardization, and has full data traceability and organization wide visibility should be the goal for any company to help them compete effectively and at the same time reduce compliance risks.