Medical device manufacturers around the world are facing an ever changing and increasingly demanding regulatory environment. This growing complexity is driving a renewed focus on digital transformation within the medtech industry, leading companies to reevaluate, expand, and update current systems. Ensuring that your company has the right software in place to implement strong processes and controls around product development, product quality, and regulatory compliance is critical. Relying on an eQMS, PLM, or RIM system that isn’t purpose-built for your needs is likely to provide inconsistent levels of functionality across your organization, and also lead to potential compliance issues.
For example, an ERP system with a configure-to-order or strong engineering focus may provide a core PLM functionality, but only a small quality module that was added late to the product. In this case, your quality and regulatory teams could be left to build custom functionality or work in spreadsheets outside of the system. To ensure that everyone in your company has the functionality they need, consider best-in-breed software for each team - including the engineering and product development, quality, and regulatory teams. Today’s technology is built with integration in mind, and there are strong reasons for integrating your PLM, eQMS, and RIM systems.
In this article, we will provide an overview of PLM, eQMS, and RIM systems - their core capabilities, strengths, and what to consider if your company is a medical device manufacturer looking to add or update software systems.
PLM for medical device manufacturers
Product Lifecycle Management (PLM) systems are typically used by product development and engineering teams to optimize resources, shorten product development time, and manage a product throughout all phases of its life. The primary functions of a PLM system include:
- Change management (ECN and ECO control)
- Product history and revision management
- Configuration management
A PLM system for a medical device manufacturer is used to mange each product’s design history file (DHF) and device master record (DMR). The PLM system will store bills of material for each revision of the product, and can therefore be integrated to a core ERP system to ensure that production adheres to the approved design.
PLM systems manage the workflow around product changes, typically including both Engineering Change Notices (ECN) and Engineering Change Orders (ECO). Change requests and execution, including reviews and approvals, can therefore be managed through one system. Medical device manufacturers may have issues, however, tracking product changes not related to the device components themselves, such as labeling changes. While it is certainly possible to track non-product changes within the BOMs of a product in PLM or ERP systems, many medical device manufacturers may move the ECN process to their eQMS system, and manage product-based ECO’s in the PLM system.
eQMS for medical device manufacturers
Quality Management Systems are built around strictly controlled workflows and closed-loop processes. Unlike a PLM system, an eQMS (Enterprise Quality Management System) system is not product-focused, it is process-focused. Some of the items that an eQMS provides centralized control for, include:
- Document control
- Non-conformance tracking
- CAPA management
- Risk management
- Supplier quality control
A strong eQMS system allows medical device manufacturers to establish quality controls from supplier to customer, and is critical for meeting the requirements of 21CFR Part 11, 21CFR Part 820, and other quality and electronic records regulations.
According to Qualio, a leading provider of eQMS systems for the life sciences industry, there are 5 Indispensable Features of Enterprise Quality Management Software:
- Company-specific features unique to your requirements - that align with the needs of your team and your processes, so that you don’t need to spend significant effort customizing and configuring the system.
- Ability to integrate processes - in order to integrate with data and processes from other systems (such as PLM and RIM systems).
- Flexible and expandable - allowing the system to grow with your company as you need new features and functionality.
- In-depth reporting capabilities - to give your teams visibility into the data they need to make effective decisions every day.
- Meets compliance standards - to make audits and compliance as easy to manage as possible.
RIM systems for medical device manufacturers
Regulatory Information Management (RIM) systems facilitate and automate regulatory activities. Regulatory affairs professionals are responsible for managing increasingly complex regulatory requirements, often across many markets. This means that RA professionals spend more than 50% of their time looking for data needed to complete regulatory submissions and ensure compliance with updated regulations. RIM systems centralize, organize, and manage all regulatory information, while automating and streamlining the regulatory processes around it. It is also worth noting that the first RIM systems were designed for the pharmaceutical industry, and did not meet the needs of medical device RA teams. RIM systems specific to the medical device industry have more recently come to market to address the needs of medtech RA teams and the increasingly complex devices and regulatory landscape they work with.
The key capabilities of a medical device RIM system:
- Product and registration management is the most central piece of functionality in any RIM system. RIM systems are product-focused (as are almost all RA activities) and enable detailed product information to be centralized and tracked, including registration and selling status by market.
- Regulatory submissions are an important and time-consuming responsibility for RA professionals. RIM systems can provide country-specific submission templates, integrate to product and quality information in PLM and eQMS systems, and allow you to manage the workflow around creating a submission document - not to mention the assembly of the final submission package.
- Regulatory intelligence is provided in some RIM systems, and solves a major challenge faced by RA teams. Regulatory requirements not only differ across markets, but can change frequently. A RIM system with a regulatory intelligence component delivers up-to-date, market-specific regulation information, along with monitoring to alert your RA team of changes.
- Essential principles and standards management supports the creation and maintenance of technical files, and GSPR/Essential principles checklists. This significantly reduces the time it takes RA teams to document when standards or product details change.
- UDI and label management may be handled separately from other regulatory activities in your organization, but integrating them within a single RIM system can simplify data collection and management, and electronic submissions to government databases.
- Project management capabilities are important in any RIM system, enabling the management of tasks, requests, and approvals around regulatory activities. RIM systems provide the traceability that regulatory teams need by keeping a detailed history of every project task, update, and approval.
- Reports and dashboards available in a RIM system provide RA teams with the information they need to understand how long regulatory submission and other processes typically take, product and market-specific registration information, and other insights that pull from the large amount of data stored in your RIM system, allowing your RA team to function as efficiently as possible!
Do medical device manufacturers need PLM, eQMS, and RIM?
We might be a bit biased, but we feel strongly that the answer to this question is “Yes.” Why? Because product development teams are expected to release new products more quickly than ever, quality teams need to ensure company-wide process meet multiple quality standards, and regulatory teams are facing an increasingly complex and quickly changing regulatory landscape. Each of these teams needs functionality built specifically for them to ensure that they are as efficient and effective as possible. Delaying a product launch, failing a quality inspection, or missing a regulatory submission deadline are not acceptable outcomes. Combine this with the fact that today’s systems are truly built with integration in mind - so that information can be shared, not duplicated, across systems. Learn more about the system that Rimsys integrates with.
If you are interested in learning more about RIM systems - read our RIM Buyer’s Guide for MedTech Companies.
And if you are interested in learning more about the Rimsys RIM system - schedule a personalized demo to see the product for yourself!
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