From Spreadsheets to Strategic Assets: Key Takeaways from Our Regulatory Data Management Webinar

Regulatory teams everywhere are feeling the pressure to do more with less. Submissions are growing more complex, data requirements are expanding, and global health authorities are moving toward structured data standards. Yet, many organizations are still relying on spreadsheets and manual processes to keep it all together.

That reality came through clearly in our recent webinar with John Popp, Manager – Regulatory Data Management at Celegence, who shared practical insights on how regulatory teams can take control of their data quality. Through three audience polls, we got a candid look at how companies are managing data today, what progress they’ve made with structured data, and the barriers holding them back.

Spreadsheets Still Rule — But at a Cost

During the webinar, our first audience poll asked: How often does your team rely on spreadsheets to manage regulatory product data?

• 57% of respondents said spreadsheets are their primary tool, used daily.
• 38% said weekly, as a complement to other systems.
• Only 5% use them occasionally, mostly for legacy products.

This reliance on spreadsheets underscores the scale of the challenge. As John pointed out, while Excel is familiar and flexible, it also creates risks: versioning issues, inconsistent ownership, and error-prone manual entries. These small cracks in data quality can become costly downstream, especially when preparing submissions.

Structured Data Adoption: Slow but Starting

The second poll asked about progress toward structured data for regulatory operations. The results show that while leaders are emerging, most organizations are still early in the journey:

• 48% of respondents are still mostly document-driven.
• 16% said they are piloting structured data for IDMP or PMS.
• 16% have started mapping structured data internally.
• 20% said they have integrated structured data across multiple functions.

John emphasized that structured data is no longer a theoretical future state — regulators are already moving in that direction. Whether it’s IDMP, PMS, or the upcoming eCTD 4.0 format, companies will increasingly need to provide data that’s exchangeable, consistent, and machine-readable.

The benefits go beyond compliance. With structured data, organizations can accelerate submissions, enable automation, and create insights that support faster approvals and earlier market access.

The Real Barriers: Governance and Alignment

If spreadsheets are the current state and structured data is the destination, what’s holding organizations back? Poll three revealed the answer:

• 40% of respondents said it was a lack of clear ownership or governance.
• 25% said cross-functional misalignment.
• 20% stated resource constraints.
• 15% said it was not seen as a priority yet.

Interestingly, nobody selected “limited automation or tooling” as their top barrier. The technology exists — what’s missing is clear accountability, data stewardship, and alignment across functions. As John noted, this is encouraging: the basics of governance are within every company’s control, and you don’t need to overhaul everything at once to make progress.

Practical Steps to Get Started

John closed with a clear call to action for regulatory teams:

• Assess current workflows – Where are spreadsheets creating the most pain? Which processes break down most often?
• Map ownership – Who enters data, who maintains it, and who’s accountable for its accuracy?
• Start small – Focus on the highest-impact areas rather than trying to “boil the ocean.”
• Build governance early – Assign roles (stewards, owners, custodians) to ensure accountability.
• Think data-first – Move step by step from document-heavy submissions to data-driven ones.

For some companies, structured spreadsheets with clear ownership may be a good interim solution. For others, moving toward centralized systems will be the right step. Either way, governance and stewardship must come first — otherwise, even the best system won’t solve the underlying issues.

Turning Regulatory Data into a Business Asset

Perhaps the most powerful idea John left us with was this: regulatory data doesn’t have to be a burden. Managed well, it can become a business asset that drives speed, insights, and strategic value.

High-quality, structured data doesn’t just make submissions faster and more reliable. It enables cross-functional collaboration, supports automation and AI use cases, and helps organizations respond more quickly to regulators. Over time, this shift can move regulatory teams from reactive firefighting to proactive data management — a change that benefits the entire business.

Final Thoughts

The poll results confirm what many in regulatory affairs already know: most companies are still spreadsheet-heavy, adoption of structured data is uneven, and governance remains the biggest barrier. But they also highlight a path forward.

Progress doesn’t require perfection or a massive system overhaul. By tackling governance, clarifying ownership, and starting with high-impact areas, regulatory teams can lay the groundwork for structured data and unlock its benefits.

As John put it, the key is simple: get started, and let your data work for you.

Contact us at info@celegence.com to learn more.