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Closing the Loop: Manufacturing & Regulatory Functions as Data Collaborators


Information gaps between manufacturing and regulatory, between ERP and RIM systems, are preventing all the practical and strategic benefits of data-based collaboration, writes Catherine Gambert.

Information gaps between manufacturing and regulatory, between ERP and RIM systems, are preventing all the practical and strategic benefits of data-based collaboration. A recent panel discussion, hosted by ProductLife Group and featuring frontline experts from K2 Consulting, Gens & Associates, LEO Pharma and Lundbeck, explored how best to turn this situation around. Catherine Gambert reports.

Catherine Gambert

For too long, manufacturing and regulatory affairs functions have soldiered on with their own systems, processes and priorities for capturing and managing data. But, as long as product data continues to be entered in different ways into different systems, in functional silos, for distinct single-function purposes, the scope for improving productivity and efficiency and delivering strategic business benefits will be limited.

So what other options are there, and what do companies have to do before they can capitalize on them? This was the topic of a recent roundtable debate among a line-up of experienced experts from across the life sciences industry.

On the panel were Steve Gens, managing partner at Gens & Associates; Kelly Hnat, principal at K2 Consulting, Jesper Kihl, VP for global regulatory affairs at LEO Pharma; Jan Vindberg-Larsen, senior director and head of global regulatory affairs at Lundbeck; Erick Gaussens, PhD, chief scientific officer at ProductLife Group (PLG); Catherine Gambert, senior consultant for regulatory affairs and regulatory information at ProductLife Group (PLG); and Loetitia Jabri, regulatory and pharmaceutical platforms associate director at PLG.

Noting that product and regulatory information has an ever greater role to play in the efficiency and strategic direction of life sciences businesses, beyond immediate administrative obligations, the panel considered how companies could make more of this – and what needed to change to make this practical.

A growing desire to transform data management

Steve Gens noted that, in his firm’s latest market research into companies’ regulatory information management (RIM) activities[i], the improvement of data management and connections to other functional areas is now a major priority for life sciences firms of all sizes. Yet, although some firms are making good progress, others are held back by the scale of change to processes and systems that are be involved – and the senior organization involvement that will be needed to effect a shift towards more routine collaborative working.

But change they must. Currently, only 14 per cent of companies have connected RIM and enterprise resource planning (ERP) systems, according to Gens & Associates’ findings. This means most information gathering and verification is being conducted manually, creating a huge data management burden, not to mention considerable scope for business risk. When information that exists across RIM and ERP systems is inconsistent, and the respective systems aren’t set up to communicate with one another, this can create complexity and vulnerability  - from compliance challenges to losses of sales based on a failure to get products to market in a timely fashion.

If information about a change control process doesn’t flow between regulatory and manufacturing, meanwhile, it can cause hold-ups in international markets. As PLG’s Catherine Gambert cautioned, “When a product gets stuck at the border because the information printed on the box isn’t the same as that in the regulatory documents, it becomes a serious issue – and this can arise because the supply chain doesn’t have access to the information in the RIM system.”

Increased data trails from digital health

It isn’t just the pharmaceutical sector that is facing practical issues because of faltering data exchange and poor visibility. The medical device sector shares many of the same challenges, and these will prove increasingly critical as regulators impose stricter regulations around device traceability.

But effective data exchange isn’t just a compliance challenge in this sector either. As the digital health movement gathers momentum, the importance of having robust data trails will only grow. “Data integrity will be a major challenge-especially when it comes to connected medical devices involving remote measurements of physiological functions,” PLG’s Loetitia Jabri explained.

One of the growing issues for all life sciences organizations is the speed and frequency with which data can change and need to be updated across all departments and systems. Fragmented data chains and system silos create points of risk.

“The objective is to make sure we all use the same source of data,” Jesper Kihl of LEO Pharma said. “We recognize the potential benefit of having more integration.” Over the last year, LEO Pharma has updated its labeling practices, for instance, so that there is more end-to-end visibility and a seamless data flow. Having seen the positive impact this can have, the company is now looking at how to apply the same treatment to other parts of the business.

Lundbeck’s Jan Vindberg-Larsen noted that his regulatory affairs organization has developed an effective infrastructure for collaborating more readily with production, allowing the two parties to share information more effectively. An SAP system is used for assessing all changes to products, including business cases; these are evaluated by commercial, regulatory and production teams before implementation.

The ability to work from the same data is also prompting broader collaboration. “We’ve also established a product committee for our marketed products,” he said. “The committee governs any major cross-functional activities and ensures alignment between regulatory affairs, production, and commercial operations on goals and priorities.”

It helps that modern software systems are now being built to be more open, in support of easier data exchange and process traceability.

Kelly Hnat of K2 Consulting noted that today’s RIM systems are very good at tracking changes to each change to a set of registered particulars about a product, the associated variation’s filing, and the approval status of that particular variation filing. “So you can see all of the changes to each registered data point in a RIM system if it’s managed properly,” she explained.

In the Gens 2018 survey, two-thirds of respondents said their companies expected to start to automate the regulatory-clinical connection over the next two years, while just over half said would start to connect and automate regulatory supply release and product change control processes.

Creating a single, holistic data source

Connecting disparate systems isn’t always straightforward, however, especially if those respective systems have their own descriptors for products. Not having a common vocabulary means it’s hard to identify data elements in one system and connect them to elements in the other.

It’s here that the prospect of master data management – building and maintaining a single, definitive version of the product truth – offers to transform things. As Steve Gens noted, “One of the initiatives for the connection of information is the standardization of terminology, so that once systems are connected they can share information seamlessly. Typically, that’s the most difficult job-the handling of terminology-rather than the connection of systems.”

“It’s not just about the differences in controlled vocabularies, but also about how data is stored, what it’s stored for, when it changes, and how it changes,” Kelly Hnat added. “Regulatory and quality teams use their systems for different purposes, and they’re tracking information at different points in the process. One of the things companies have to be cautious about when implementing master data management is not only the importance of finding out who owns the data but also the purpose of the data, when it was updated, etc.” Although data captured for IDMP regulatory purposes focuses on what’s registered, it doesn’t necessarily cater for what the manufacturing site is doing,” she noted. So master data approaches need to extend beyond specific use cases.

PLG’s Erick Gaussens suggested that an effective approach to keeping all of the fuller data sources and supporting documents aligned can be to layer the RIM system on top of the ERP system, maintaining control of the metadata.

Whatever the broader opportunities, it is typically the intensifying regulatory demands that continue to drive improvements and free up the necessary budget. Companies are aware that initiatives such as IDMP and the Falsified Medicines Directive mean data must become more integrated, so functions have become more willing to spend time and resources on building bridges and establishing interfaces.

But it’s those organizations that have also identified the wider business benefits of more streamlined data management that have seen the greatest scope to modernize and innovate. At LEO Pharma, Jesper Kihl, explained how his team has used IDMP to highlight the broader potential for greater efficiencies and closer connection between functions. He hopes that IDMP implementation timelines will be brought back on track by regulators soon, when a higher sense of urgency will help drive through the benefits.

When a company treats data as a corporate asset and maintains it in the form of definitive master data, the whole organization stands to benefit from an environment in which data can be trusted as being a high-quality record of the latest truth, the panel agreed.

Ultimately, this makes everyone’s life easier, makes processes slicker, and drives out cost and risk, while supporting greater market agility. Since these are benefits that all organizations are striving to deliver, the case for radically transforming data management and the scope for reliable data exchange and re-use between and beyond each immediate department is a strong one.

Catherine Gambert is senior consultant for regulatory affairs and regulatory information at ProductLife Group. www.productlifegroup.com

[i] World Class Regulatory Information Management Whitepaper: Connections to Supply Release, Product Change and QMS, Gens & Associates’ 2018 (a study of RIM priorities and status in 69 companies globally): http://gens-associates.com/wordpress/wp-content/uploads/2018/10/GensAssociates_ExecutiveWorldClass_RIM_Whitepaper_Fall2018_Edition_101218.pdf

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