Biotech & pharma quality and validation
VeraRisk — risk classification built around your SOP, not around the tool
VeraRisk (working name) is a purpose-built tool for the GxP risk-based classification and functional risk assessment step — the step enterprise validation platforms treat as a footnote.
How it works
Encodes your governing SOP
The SOP is encoded verbatim — including the Severity Override Rule and Appendix A deliverables — so classification follows the procedure your team is already assessed against.
Emits structured output
Trace-matrix skeletons and structured JSON flow straight into downstream protocol and execution tools, rather than terminating in a document nobody can query.
Fits the existing workflow
Built for biotech and pharma quality and validation teams — the classification step slots into the validation lifecycle you run today, not a replacement for it.
The regulatory frame
VeraRisk is designed around the following frameworks. These are the standards the product is built to align to — not certifications it holds, and not audits it has completed.
- FDA 21 CFR Part 11
- GxP (GLP, GCP, GMP)
- ALCOA+
- GAMP 5 (2nd Ed)
- ICH Q9(R1)
- EU Annex 11 / 15
- PIC/S PI 041
- FDA CSA
Where it stands
A working proof-of-concept
VeraRisk is currently a working single-user proof-of-concept. It is not generally available, and we'd rather say so plainly than let a demo imply otherwise. We're looking for validation teams who want to shape what it becomes.
Where it's headed
AI/ML governance
The same classification discipline extends naturally to AI and ML systems entering GxP-regulated processes — the differentiated expansion path we're building toward.
Shape it with us as a design partner
If your team owns risk classification and you've felt where the current tooling stops, we'd like to talk.