The CDMO deviation reporting problem is structurally different
CDMOs run batches for multiple sponsors simultaneously. Each sponsor has different deviation reporting requirements, different timelines, and different oversight expectations.
What makes CDMO deviation management different
Multiple sponsors, simultaneous batches, different reporting obligations
A CDMO with eight active bioreactor lines running product for four sponsors has four different deviation reporting timelines, four different report formats, and four different sponsor QA contacts. Fermentile manages these as separate investigation streams with sponsor-specific output formatting.
The 72-hour window is contractual, not aspirational
Sponsor deviation notification requirements are written into CDMO supply agreements. The 72-hour commitment means 72 hours from detection to sponsor-readable report. Fermentile's sponsor report generation is part of the investigation workflow, not a separate step after it.
Sponsor audits and regulatory inspections have different requirements
Fermentile's investigation packages support both sponsor audits (client-specific batch documentation) and regulatory inspections (cross-batch quality trend data for the CDMO's overall quality system).
Multiple processes, scales, and clients simultaneously
Fermentile's batch comparison engine matches batches within the correct process and scale context. Deviation classification uses process-specific SPC limits derived from the site's historical data for each process, not a single CDMO-wide threshold.
Sponsor deviation reports: formatted within the investigation window
Formatted sponsor package generated from the investigation record
Once a deviation investigation is approved, Fermentile generates a formatted sponsor report from the investigation record. The report includes the deviation summary, root-cause classification, corrective action, batch comparison context, and electronic approval trail. Your quality team reviews and approves — they do not write it from scratch. The sponsor receives a formatted PDF with the depth and structure their QA team expects.
Sponsor audits do not require investigation reconstruction
All deviation records for a specific batch scope
Fermentile returns every investigation record for the requested batch scope, including timeline, root-cause classification, CAPA record, and electronic approval trail. No manual document compilation from disparate systems required.
CPV compliance data for all registered processes
The CPV dashboard generates a compliant report from current data across all registered processes — control charts, capability indices, and trend findings. The audit trail for each investigation is complete and traceable to the source data record.
Verify corrective action effectiveness across subsequent batches
After a CAPA is implemented, Fermentile tracks the relevant parameters in subsequent batches to verify the corrective action closed the deviation pathway. CAPA effectiveness evidence is generated from batch data, not a manual follow-up worksheet.
Start with one client's batch family
A Fermentile pilot for a CDMO runs on a single sponsor's process — one product, one scale, one deviation investigation workflow. We connect to your existing data infrastructure and validate the deviation classification against the client's historical batch population before going live. Typical pilot duration: 30 days.