5 Questions Every Cell Therapy Organization Should Ask Before Their Next FDA Audit
Preparing for an FDA audit in cell therapy isn’t just about documentation, it’s about readiness across people, processes, and technology. For patients whose treatment depends on precise, time-sensitive coordination, every operational detail matters. A single delay in scheduling, a missing timestamp, or an outdated SOP can extend a patient’s wait for a therapy they urgently need.
In recent years, our team at Pragmatrix has observed one pattern across CMOs, CDMOs, and therapy developers: successful audits don’t happen in the audit room. They happen in the months leading up to it – inside workflows, touchpoints, and systems that either support teams or slow them down.
As cell therapy volumes grow, these five questions can be the difference between a smooth audit and unexpected findings.
1. Are our SOPs consistently followed or only consistently documented?
In cell therapy, every step connects to patient safety: Chain of Identity (COI), Chain of Custody (COC), batch processing, environmental checks, and scheduling. Teams often focus on documenting procedures, but the real question regulators assess is: are these procedures followed in practice?
Manual transcriptions, siloed spreadsheets, and inconsistent handoffs create variability. Even well-trained staff can unintentionally miss steps during busy cycles.
Organizations can strengthen consistency by ensuring:
- SOP steps guide work, not just record it
- Deviations surface early instead of after the fact
- Updates apply across teams at once
- Batch records reflect real-time actions
With PragLife, SOP alignment becomes part of the workflow. The system guides users step-by-step, reducing reliance on memory and manual checks while creating a clear, FDA-ready trail of what actually happened during production.
2. Can we trace every action, person, and material throughout the therapy journey?
COI and COC tracking remain two of the most closely reviewed elements of an FDA audit. In autologous therapies especially, each step links back to a single patient, which means every entry, approval, and movement must be traceable without gaps.
Teams preparing for audits often discover:
- Inconsistent timestamp formats
- Missing intermediary touchpoints
- Paper notes that don’t match digital logs
- Delayed updates due to manual reconciliation
Auditors expect precise, end-to-end traceability, from collection through manufacturing and final delivery.
PragLife automates this chain. Each scan, transfer, approval, and storage step is recorded in real time, enabling seamless COI/COC continuity and eliminating the need to cross-check multiple systems during audits. Organizations looking to strengthen their COI and COC processes through software implementation often find this approach significantly reduces audit preparation time.
3. Do our manual processes introduce delays that affect patient timelines?
Behind every therapy is a patient waiting for treatment, often while managing a rapidly progressing condition. Teams feel this urgency every day, yet many still rely on manual coordination for scheduling, sample movement, and batch actions.
The result: Small delays accumulate. Teams work harder to keep pace. Patients wait longer without knowing why.
Audit reviewers increasingly consider operational impact. When delays stem from process variability, regulators expect organizations to demonstrate improvements.
With PragLife’s automated scheduling and workflow orchestration:
- Appointments align with manufacturing capacity
- Notifications reach the right teams automatically
- Time-sensitive steps trigger alerts
- Teams gain visibility before bottlenecks form
When coordination becomes predictable, patient timelines become more reliable and audit conversations become easier. This is where cellular orchestration platforms demonstrate their greatest value – transforming fragmented processes into unified, compliant systems.
4. Are our quality processes proactive or reactive?
Quality teams often carry the burden of catching issues late in the cycle. Missing documentation. Offline logs. Disconnected data sources. These issues create extra effort during audit preparation.
Modern GMP expectations favor systems that help teams stay ahead of issues, not simply document them.
Organizations with proactive quality systems:
- Identify deviations early
- Maintain audit trails without extra steps
- Connect environmental, manufacturing, and logistics data
- Reduce back-and-forth between departments
PragLife’s quality features surface exceptions in real time, giving teams both visibility and context. Instead of searching through binders or shared drives, investigators can follow a clear, unified trail – minimizing the stress that typically surrounds audits.
The transition from paper-based processes to electronic SOPs for GMP compliance has proven instrumental in achieving this proactive approach to quality management.
5. Can we demonstrate consistent compliance across every site, partner, and shift?
Multi-site therapy programs, distributed manufacturing models, and collaborations with partners make consistency difficult. Even small variations between sites can become audit findings.
Regulators want to see:
- Standardized workflows
- Harmonized data across locations
- Controlled configuration changes
- Centralized oversight without disrupting local operations
PragLife’s modular architecture supports this operational reality. Organizations configure the platform to match their validated processes while maintaining oversight across all facilities. Each site follows aligned workflows, while local differences are respected within controlled parameters.
How PragLife Helps Teams Enter Audits with Confidence
PragLife was built for GMP environments where precision and compliance are core requirements. Across manufacturing, quality, and logistics, the platform:
- Guides teams through SOP-aligned workflows
- Maintains complete COI and COC traceability
- Surfaces exceptions before they become larger issues
- Unifies scheduling, production, storage, and quality data
- Creates audit-ready records without extra work
This helps organizations not only prepare for FDA audits, but improve operational efficiency and patient delivery timelines year-round.
For more insights on optimizing your operations, explore how supply chain integration enables seamless connectivity across the cell therapy ecosystem.
Conclusion
FDA audits in cell therapy aren’t about passing a test, they’re about demonstrating that every therapy, every batch, and every patient journey is handled with consistency and care. Asking the right questions early helps teams stay aligned, reduce risk, and ensure patients receive their treatments as quickly and safely as possible.
If your organization is preparing for an upcoming audit or scaling your cell therapy program, our team is here to help. Learn more about PragLife or reach out to our team to discuss your specific requirements.
