Why Disconnected QMS and RIMS Are a Significant Commercial Risk

“This product is not approved to be imported into our market,” the customs official said.

The local quality and regulatory teams scrambled. The product registration had been valid for years. No local variations had been filed, because no product changes or updates had been communicated. But the customs inspector, cross-referencing digital registration records against the incoming products and shipping documentation, had identified discrepancies. 

How did this happen? Without coordination between global quality and regulatory teams, a manufacturer had executed changes—internally deemed immaterial to the U.S. and EU markets—without realizing the need to assess global registration implications in local markets. Separately operating in siloed systems, the local regulatory team had no automated visibility into quality management system (QMS) activities at the company’s manufacturing site, making it difficult to identify product changes that were significant to their local market registration.

When quality change is managed separately from regulatory lifecycle management activities, because quality and regulatory information reside in disconnected and systems, the risk of that gap can remain invisible until it explodes.

While hypothetical, this scenario mirrors real-world failures that play out frequently in the medtech industry. For medical device and in-vitro diagnostic organizations, the disconnect between manufacturing QMS and global regulatory information management systems (RIMS) represents one of the most underappreciated compliance and commercial risks in company market access activities.

A Structural Problem Built Into Commercialization

Embedded in the legacy of life sciences manufacturing, the QMS/RIMS disconnect is a significant hindrance to companies looking to accelerate the timely provision of safe and effective product solutions in global markets. Quality and regulatory functions, while entwined in core elements of activity, evolved over decades with a slightly different focus and became further separated as specialized software platforms were introduced to support each department.

A QMS formalizes processes and procedures that help a company meet global regulations in the design, manufacture, sale, and distribution of its healthcare solutions. RIM solutions streamline the management of regulatory submissions, product registration, and lifecycle management activities necessary to obtain and maintain global country approvals. While there is a connection between content and data used in the two systems, such a distinct split in use cases and target customers creates two separate solutions, each used in a different department within the same organization.

Normally, any change made at a manufacturing site that has downstream regulatory implications must cross organizational boundaries (and multiple teams) before being entered into the system that tracks regulatory commitments. The gap has historically been bridged through email threads, spreadsheets, and hope. That once was enough, as product portfolios were smaller and regulatory environments were more stable. The number of global registrations each device required was manageable. But those days are gone due to increased product complexity, innovative technologies, and evolving global regulations.

Factors That Make QMS and RIM Integration Non-Negotiable

1. Regulations continue to evolve across global markets. The EU Medical Device Regulation and In Vitro Diagnostic Regulation raised the bar for initial EU market access and created new, ongoing obligations that impact both quality and regulatory functions. Unique device identification system requirements link quality record-keeping to regulatory submission content. Post-market surveillance requirements will feed data directly back into activities that may drive product changes (and updates to global regulatory submissions). Similar regulatory evolutions exist in many global markets for both vertical healthcare regulations and the horizontal, industry-wide regulations. A manufacturing change event and/or regulation update occurring in one country could require multiple, separate evaluations to assess the impact of that change elsewhere.

From a company perspective, this means the upstream/downstream impact of changes required at the manufacturing site has a greater need to seek input from global country teams before a change plan is finalized. Without this, the compliance and commercial risks associated with managing those changes across disjointed systems is high.

2. Regulatory enforcement spans datasets. Current site audits routinely compare quality records to regulatory submissions. Customs officials worldwide now have digital access to their countries’ product registration databases. Thus, a manufacturer’s device master record changes must accurately match local country registered information (i.e., part number, labeling, part chemistry) or it will be flagged. For medtech companies, internal quality decisions have downstream regulatory consequences, which can be amplified globally.

3. The costs of manual reconciliation are rising. Personal relationships between manufacturing teams and local country teams, between quality and regulatory professionals, may have sufficed in the past. But today, those same connections pose direct compliance risks that increase with employee turnover, team restructuring, and other predictable breakdowns when too many people are involved in what should be a simple handoff. An electronic note from one quality engineer to one regulatory professional, reminding them of something important, is not a process.

The hidden costs of disconnected QMS/RIMS include duplicate data entry on both sides, version control issues caused by misaligned data and document sets, submission delays due to country regulatory teams not having access to core manufacturing product documentation, and avoidable “near misses” that require hours or days to remediate.

4. Speed to market is a competitive advantage. Revenue is won and lost based on speed to market. Global manufacturers that enable their local country partners to promptly prepare accurate, compliant global submissions on demand, because their quality processes integrate directly with the local country regulatory workflows, will win business. Conversely, those that introduce friction at the quality-regulatory interface and operate with siloed QMS and RIM solutions will lose ground.

Failure With Disconnected QMS and RIM Solutions

What happens when QMS and RIMS fail to communicate in a company’s enterprise technology footprint? Some common repercussions include: 

• Change control surprises. During change control, a product change may be deemed acceptable based on the manufacturer’s quality assessment criteria, driven by familiarity with local country regulations. That same change may require modifications to registrations in global markets where the company is present and for which the manufacturing-based decision maker was unaware of the local country registrations (and associated requirements).
• Critical documentation waits. Global regulatory teams building global submissions must often wait on quality documentation from their manufacturing colleagues. The documents may exist within a QMS, but they can’t be quickly located, verified, or shared because the QMS is not connected to RIM solutions, and the local country regulatory professional does not have direct access to documentation in the manufacturing QMS.
• Overlooking regulatory changes that impact the site. Countries can update their regulatory requirements, and those updates sometimes affect the manufacturing activities, product specifications, and design inputs. In a disconnected world, that information is often communicated too late (or not at all), resulting in delays in meeting global regulatory requirements.
• AI potential wasted. Connected and single-platform QMS and RIM solutions provide consistent data, document, and content backbones and drive interconnected processes in a digital way that reduces risk, improves resource utilization, and accelerates quality and regulatory professional activities. This same infrastructure allows the cost-effective and timely roll-out of AI augmenters and accelerators that drive additional process and performance gains. This all drives improved operational performance, market access, and compliance.

There is no larger waste than the invisible: productive hours lost by talented professionals struggling to navigate systems that should work together, multiplied across siloed organizations that sit within the same parent company that should, but don’t always, seamlessly align.

The Integration Imperative for QMS and RIM Solutions

For medtech manufacturers, closing the QMS/RIMS gap is a two-way street, but it starts with awareness. Every quality or regulatory change that could potentially affect globally registered products should go through a connected workflow to make a conscious, global impact assessment before finalizing a change plan. Before establishing such a connection, however, organizational leaders must understand the current gaps in their existing QMS and RIM infrastructure. Key questions include:

• How many times have manual processes been used to bridge the digital divide? 
• Where are decisions being made without visibility into the activities transpiring in related systems? 
• Where have past near misses occurred due to missing or unavailable important information?
• What is the annual cost to remediate manufacturing changes that have not been pulled through into local market registration updates?
• What is the impact to customers and patients from customs importation and inventory management issues triggered by disconnected change management activities?

The number of potential gaps could surprise many medtech manufacturers who seriously examine the disparity between QMS and RIMS. Consequently, connecting quality and regulatory functions will likely become a priority—because the financial and patient impact consequences of keeping them separate are significant.

Change is coming for life sciences regulations. Product portfolios will continue to expand, and the intra-company partnerships required to manage that growth will become more complex. Medtech manufacturers that bridge the QMS/RIMS divide between their manufacturing and global country regulatory teams will lead the market in responding to that change. Those who don’t will continue to react to the next crisis. And risk being shut out of the market at a cost to patients.

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Mike King has spent about 20 years leading localized and global teams in regulatory affairs and quality assurance. He focuses on optimizing business workflows through intelligence-driven simplification and automation within and across the quality, regulatory, and safety functions.