If you work in regulatory affairs, you have probably seen this moment.
A message comes in from leadership:
“Can you confirm which markets are up for renewal in the next 90 days, and which variations are still open?”
You open the registration tracker.
Then you realize there are multiple versions of it, each updated by different people, each telling a slightly different story.
That is the point where an Excel tracker stops being a helpful list and starts quietly running your regulatory operation.
For many medicinal product teams, this shift happens somewhere around 500 licenses. Not because Excel suddenly fails technically, but because the way regulatory work scales no longer matches what a spreadsheet is designed to support.
This article explains why that tipping point is real, what it costs teams in practice, and what a scalable alternative looks like when portfolios grow beyond what manual tracking can reliably sustain.
When a tracker becomes the operating model
In medicinal products, a “license” is not a static approval. It is an obligation that must be maintained over time.
Each license brings ongoing work, including:
- renewals and extensions
- lifecycle submissions and variations
- commitments and post-approval obligations
- country-initiated updates
- global changes initiated centrally that must be implemented locally
That is not list management. It is lifecycle management.
As long as the portfolio is small, Excel can absorb that complexity through effort. As the portfolio grows, the level of effort required becomes the constraint.
Why 500 licenses is a real tipping point
There is nothing magical about the number itself. The math behind it is straightforward.
A realistic portfolio might look like this:
- 12 products
- 20 markets per product
- 2 strengths or presentations
That is already close to 500 licenses. Add line extensions, local packs, or staggered approvals, and the number climbs quickly.
At that scale:
- more people touch the tracker
- more changes happen in parallel
- reporting becomes more frequent and more visible
- the cost of being wrong increases
What worked at 100 licenses starts to feel fragile. What felt manageable becomes reactive. This is why Excel-based registration trackers often feel sufficient until they gradually stop being reliable.
Seven ways Excel registration trackers fail at scale
These failures are not theoretical. They show up repeatedly once portfolios cross a certain size.
- Version chaos replaces a single source of truth
As teams grow, trackers multiply. Headquarters versions, affiliate copies, functional extracts, email attachments. Even with good intentions, updates drift. Reporting turns into reconciliation. - Renewals and obligations turn into fire drills
Excel can store dates, but it cannot run a process. Ownership is often unclear, reminders are manual, escalation happens late, and evidence is scattered across folders and inboxes. - Change impact becomes manual and risky
One change can affect dozens of licenses. In a spreadsheet, impact analysis usually means searching, filtering, and hoping nothing was missed. At scale, something eventually is. - Audit questions are hard to answer quickly
Questions like “who changed this date” or “what was the previous status” are difficult to answer without heavy controls. Most teams do not have the capacity to enforce that rigor continuously. - Reporting becomes brittle
Leadership asks for views on renewals, backlogs, readiness, and commitments. Excel formulas and filters do not age well under constant change. Confidence in the numbers drops. - Global handovers break collaboration
Work moves between headquarters, regions, and affiliates. Spreadsheets do not support structured handoffs, which leads to follow-ups, clarifications, and duplicated effort. - Free-text tracking collides with structured data expectations
Even if a team is not actively working on structured data initiatives, expectations are moving in that direction. Free-text trackers make standardization harder over time, not easier. The flexibility of Excel becomes the very thing that limits it.
Excel versus a RIMS approach at 500+ licenses
At scale, the difference is not about tools. It is about control.
| What teams need at 500+ licenses | Excel tracker reality | RIMS-based reality |
|---|---|---|
| One source of truth | Multiple versions and conflicting updates | Centralized records with controlled access |
| Dependable renewal tracking | Manual reminders and late escalation | Ownership, workflows, and visibility |
| Fast change-impact checks | Manual filtering and high risk of misses | Linked product, registration, and lifecycle records |
| Audit-ready traceability | Difficult to show history and rationale | System-supported traceability and accountability |
| Trusted portfolio reporting | Brittle formulas and inconsistent metrics | Consistent dashboards across the portfolio |
This is the point where teams realize they are no longer managing registrations. They are managing the tracker.
What to do instead: a practical path forward
Moving beyond Excel does not require a disruptive transformation. The key is to introduce structure where it matters most, then scale deliberately.
Step 1: Lock a minimum data model
A scalable registration model typically includes:
- product
- application
- registration
- license information
- lifecycle submissions
- lifecycle management items such as renewals, obligations, PSURs, and commitments
When this structure exists, reporting and impact analysis stop being manual detective work.
Step 2: Standardize the fields that always cause problems
If nothing else, standardize:
- product naming
- country and region values
- application and procedure types
- status values
- key dates and milestones
- ownership fields
This alone reduces confusion and enables reliable reporting.
Step 3: Add operational control, not just storage
At 500+ licenses, teams need more than a place to store data. They need:
- workflows
- notifications
- planning and tracking
- consistent reporting
- searchable history
This is the difference between a tracker and a system.
Step 4: Adopt in phases
A realistic path often looks like:
- centralize license and lifecycle tracking
- stabilize ownership and reporting
- expand into connected use cases over time
Trying to do everything at once usually slows progress.
Warning signs your Excel tracker is already costing you
| Warning sign | What it usually leads to |
|---|---|
| “Which file is the latest?” comes up weekly | Inconsistent reporting and wrong decisions |
| Renewals are managed in email threads | Missed deadlines and reactive escalation |
| Variations are tracked in regional tabs | Incomplete visibility and delayed closure |
| Impacted licenses cannot be listed quickly | Higher compliance risk and rework |
| Leadership reports cause panic | Time spent preparing slides instead of progressing work |
| New team members struggle to onboard | Repeated mistakes and slow ramp-up |
If several of these feel familiar, the cost is already being paid in time, stress, and lost confidence.
How freya fusion supports scale without adding complexity
Regulatory teams need systems that support real work, not abstract frameworks.
freya fusion is designed as a unified regulatory platform, bringing together structured data, lifecycle tracking, and workflow support so teams are not forced to maintain the same information across multiple tools.
freya.register: centralized license and lifecycle management
For teams under pressure from scale, registrations and lifecycle management are the natural starting point.
freya.register supports management of:
- products and applications
- registrations and license information
- lifecycle submissions
- renewals, obligations, PSURs, and commitments
- global and local changes, with visibility across markets
This is the structure Excel struggles to sustain once portfolios grow.
Learn more: https://www.freyafusion.com/products/freya-register
Where AI adds value (and where it does not)
AI is most useful where Excel breaks first: impact awareness, consistency checks, and visibility across connected records.
Within freya fusion, AI is applied to:
- support identification of potentially impacted registrations when changes occur
- assist with completeness and consistency checks before submissions
- help route and track health authority queries with clear ownership
- assist in associating documents with the correct regulatory context
AI supports readiness and informed decision-making by surfacing impacts and inconsistencies, while regulatory decisions, approvals, and compliance accountability remain with people.
For teams dealing with high query volumes, see: https://www.freyafusion.com/products/freya-rtq
For document control at scale: https://www.freyafusion.com/products/freya-docs
Final thoughts
Once portfolios cross 500 licenses, the Excel challenge is no longer about spreadsheets. It is about the level of control required to manage interconnected, deadline-driven regulatory work.
Key takeaways:
- Excel becomes increasingly difficult to sustain at scale when registrations are connected, deadline-driven, and audit-sensitive
- The biggest risks are version drift, manual impact analysis, and unreliable renewal tracking
- A scalable RIMS approach introduces structure, ownership, workflows, and reporting that teams can trust
- freya fusion provides a unified foundation so teams can scale without losing visibility or accountability
If your tracker feels like it is running the operation rather than supporting it, it may be time to revisit the model.
Explore freya.register here:
https://www.freyafusion.com/products/freya-register
If you want to discuss a practical migration path from your current tracker, book a demo or speak with the team.