5 Signs Your Lab Has Outgrown Spreadsheet-Based Sample Tracking (and What to Do Next)
Spreadsheets have supported life sciences teams for decades. They’re familiar, flexible, and quick to set up.
But as labs scale, especially in regulated environments like cell therapy, biobanking, and advanced biologics – what once worked can quietly become a source of risk.
Over the years, our team at Pragmatrix has had the opportunity to work alongside CDMOs, CMOs, and biotech organizations navigating this exact transition. A consistent pattern emerges: spreadsheets don’t usually “fail” overnight. They simply stop keeping pace with operational and regulatory realities.
Here are five signs your lab may have outgrown spreadsheet-based sample tracking and key considerations for moving forward.
1. Traceability Lives Across Too Many Files
In early-stage operations, a single spreadsheet might be enough to log samples, locations, and dates.
As volumes grow, that one file becomes many:
- One sheet for freezer locations
- Another for Chain of Custody
- Another for Chain of Identity
- Separate logs for deviations or exceptions
The challenge isn’t effort, it’s consistency.
In FDA-regulated and GMP environments, traceability needs to be continuous and defensible. When data is fragmented, reconstructing a complete sample history for audits or investigations becomes time-consuming and error-prone.
What we’ve observed: Teams spend more time reconciling data than improving processes.
2. SOPs Are Documented, but Not Enforced
Most organizations have well-written SOPs aligned with regulatory expectations. The issue is execution.
Spreadsheets rely on people to remember:
- The correct sequence of steps
- Required approvals
- Mandatory checks
There’s no built-in mechanism to ensure SOP adherence at the moment work happens.
As operations scale, this creates variability – especially across shifts, sites, or partners. In cell and gene therapy workflows, even small inconsistencies can impact patient safety and compliance.
Transition consideration: Modern systems should support SOP-aligned workflows, not just store documentation.
3. Audit Preparation Is Manual and Stressful
Audit readiness often becomes a litmus test for operational maturity.
With spreadsheets, preparing for FDA inspections or internal quality reviews typically involves:
- Pulling data from multiple sources
- Manually validating timestamps and changes
- Explaining how controls are maintained
This approach may work occasionally, but it doesn’t scale well.
Regulations increasingly expect real-time visibility, validated electronic records, and clear audit trails, especially under frameworks like 21 CFR Part 11.
The real signal: When audit preparation feels like a project instead of a byproduct of daily operations.
4. Sample Volume and Complexity Are Increasing
Growth is a good problem to have.
But higher sample volumes, multiple therapy types, and expanding clinical programs introduce complexity spreadsheets weren’t designed for:
- Autologous vs. allogeneic workflows
- Different storage conditions
- Multiple handoffs across the Chain of Custody
As cell therapy programs mature, maintaining precision across these variables becomes critical.
Industry reality: Personalized therapies demand systems that scale without increasing manual effort.
5. Data Integrity Depends on Manual Controls
Spreadsheets are flexible, but that flexibility comes with tradeoffs.
Version control, access management, and change tracking often depend on informal rules rather than system-level controls. In regulated environments, that creates uncertainty around data integrity.
When patient safety and regulatory trust are involved, “best intentions” aren’t enough. Controls need to be embedded into the system itself.
What leading organizations prioritize: Validated platforms that support compliance by design.
How PragLife Supports This Transition
PragLife was built specifically for regulated life sciences environments where traceability, compliance, and scalability are non-negotiable.
Our modular platform helps organizations move beyond spreadsheets by supporting:
- End-to-end traceability across Chain of Identity and Chain of Custody
- SOP-aligned workflows embedded into daily operations
- Electronic batch records designed for GMP environments
- Audit-ready documentation available in real time
- Configurable implementation, allowing teams to start where they need most and expand over time
Importantly, PragLife is designed to work with existing validated processes – supporting change without disruption.
A Practical Next Step
Spreadsheets aren’t a mistake, they’re often a starting point.
The question many organizations are now asking is when to transition, not whether to.
If your team is spending more time managing tools than advancing science, it may be time to reassess your sample tracking foundation.
We’re always open to a thoughtful conversation about how PragLife might support your next stage of growth – at your pace, aligned with your regulatory and operational needs.
