Your regulatory team needs dedicated regulatory software

By
Wendy Levine
-
March 7, 2022
Your regulatory team needs dedicated regulatory software

Prioritize the needs of your regulatory team

Regulatory affairs teams are responsible for highly critical components of a medtech company’s success, including:

  • Market Entry: Meeting go-to-market goals by ensuring accurate, timely market registrations and approvals.
  • Regulatory Integrity: Protecting a product’s market position by maintaining regulatory compliance within an ever-changing regulatory landscape.
  • Post-market Compliance: Ensuring compliance with post-market surveillance and reporting requirements specific to each market and each device classification.

Your regulatory team should be focused on positioning your products for success in every market you enter.  But, did you know that regulatory professionals spend between 30% and  50% of their time looking for the data that they need to do their jobs?  This is because many regulatory teams are still using spreadsheets or manually pulling together data from eQMS, PLM, ERP, and other disjointed systems to track the information they need to ensure compliance across markets.

RIM systems compared to eQMS systems

Regulatory Information Management (RIM) systems provide a platform purpose-built for regulatory teams.  There are quality systems that provide some regulatory functionality, such as tracking  product registrations and even supporting the creation of submission documents.  However, these systems fall far-short of providing holistic regulatory management functionality.  While functionality can vary among eQMS and RIM systems, RIM systems tend to offer the following features above and beyond what you will find in eQMS modules:

Standards management

International standards play a critical role in regulatory affairs. Regulatory teams need to track which standards are relevant to their products, and link them to product records and/or technical documentation. Any changes to standards can be captured, and impacts to products can be identified automatically.  A good RIM system will flag regulatory changes, identify the affected products, and track updates and approvals as needed.

Essential principles management

As more countries and regions around the world adopt Essential principles or GSPR requirements, the regulatory burden of creating and maintaining complex technical files grows. In addition to tracking international standards, RIM systems can fully digitize essential principles/GSPR tables,  and allow users to link them to relevant standards and products.  This structure allows regulatory teams to easily author, and, more importantly, make automatic bulk updates to tables when standards or product details change. 

UDI management

Another growing regulatory burden is the proliferation of UDI requirements. UDI has traditionally been considered a labeling or supply chain concern, but the growing number of country requirements mean that UDI data management is a key component of getting any product to market. RIM systems can manage country-specific UDI data alongside products, registrations, certificates, and other regulatory documents, allowing regulatory teams to ensure that UDI information is correct and up to date. 

Regulatory Intelligence

One of the reasons that regulatory teams spend so much time looking for information is that it’s simply hard to find trustworthy regulatory intelligence. Some RIM systems provide a regulatory intelligence database along with their digitization and automation capabilities. This means that regulatory teams have access to quality (well-translated) information, and can use it directly within their processes.

RIM Integrations

RIM systems are also built to integrate with eQMS, PLM, and ERP systems providing a strong regulatory framework across the company, including:

  • The ability to use product ‘selling status’ in the RIM system to control the ability to market and sell the product in the company’s ERP system (on a product-by-product and country-by-country basis).
  • Ensuring consistent and up-to-date SKU lists between product submissions being created in RIM systems and product development being tracked in PLM systems.
  • Triggering regulatory impact assessments when quality records are updated in the eQMS .
  • Providing consistency in regulated data among manufacturing, engineering, and regulatory data.

Why you want best-of-breed software: The “all-in-one” myth

Much of the software developed today is designed with integration in mind, and API integrations make it possible to create direct, customized links between separate systems. The days when system integrations meant custom code, batch imports, and clumsy (sometimes unreliable) data synchronization are gone. 

This means that organizations can, and should, choose the right software for each task or team. The ability of your regulatory team to work effectively and efficiently is critical to the success of your product market launches, regulatory submissions, and the on-going management of each product in each market. Don’t make them settle for functionality in another team’s system - give them software designed specifically for their needs!

“Best-of-breed,” purpose-built software for each team not only gives everyone in your organization the tools they need to be most productive and successful, but minimizes the costs and risks associated with customizing systems to do something they were not meant to do.

To learn more about RIM tools, read the Rimsys Benefits data sheet.


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