The manufacturing-regulatory continuum: improving data flow

How to transform inter-departmental collaboration in life sciences

The more readily different parts of life sciences organisations can share good-quality data with each other, the greater the benefits for everyone concerned. But this is often easier said than done. If data continues to be entered in different ways into different systems, across functional silos, the scope for improving productivity, efficiency and delivering on strategic goals will be limited.

But what other options are there, and what exactly is involved in a ‘master data management’ approach?

These issues were the subject of a recent roundtable debate among experienced industry experts. 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.

RELATED: Hear from Richard Caron, Associate Director, Global MQIT at Eli Lilly on Implementing a Digital Road Map to Transform Quality/ Manufacturing Operations in his upcoming webinar. Register for free here.

Maximising the value of product lifecycle data

Steve Gens noted that, in his firm’s latest market research into companies’ regulatory information management (RIM) activities[1], the improvement of data connections between functional areas is now a major priority in life sciences.

Currently, only 14 per cent of companies have connected RIM and enterprise resource planning (ERP) systems. This means most information gathering and verification is being conducted manually, creating a huge data management burden and considerable scope for risk - from compliance challenges to losses of sales based on a failure to get products to market in a timely fashion.

86% of companies have yet to connect their RIM and ERP systems

If information about a change control process doesn’t flow between regulatory and manufacturing, it can cause hold-ups in international markets. “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.”

The accelerating pace of change

It isn’t just the pharmaceutical sector that is facing practical data-related issues. The medical device sector is coming under increasing pressure to improve device traceability and patient safety.

But, here too, effective data exchange isn’t just a compliance challenge. “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 organisations is the speed and frequency with which data can change and need to be updated across all departments and systems.

Maintaining data integrity as the pace of change increases is a major challenge

“The objective is to make sure we all use the same source of data,” Jesper Kihl of LEO Pharma said. Over the last year, the company has updated its labelling practices, so that there is more end-to-end visibility and a seamless data flow. Next, it hopes to apply the same treatment to other parts of the business.

Lundbeck’s Jan Vindberg-Larsen noted that his regulatory affairs organisation collaborates with production via an SAP system for assessing all changes to products, including business cases; these are evaluated by commercial, regulatory and production teams before implementation.

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Creating a single, definitive source of truth

Another challenge to overcome is where systems each have their own descriptors for products. Moving towards a single master data resource can help here.

As Steve Gens noted, “One of the initiatives for the connection of information is the standardisation of terminology, so that once systems are connected they can share information seamlessly. Typically, that’s the most difficult job, rather than the connection of systems.”

Standarizing information so systems can share information can be more difficult than the process of connecting systems

Other challenges surround where data is stored, what it’s stored for, when it changes, and how it changes, K2’s Kelly Hnat added. 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.

The panel agreed that the whole organisation stands to benefit from an environment in which data can be trusted as a complete record of the latest truth. Which in the long run makes everyone’s life easier, makes processes slicker, and drives out cost and risk, while supporting greater market agility.

[1] 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