Trust & Compliance
What pharma QA can expect from a software vendor — precise, regulatory-aware, no marketing speak.
Compliance Posture
| Framework | Status | Note |
|---|---|---|
| EU Annex 11 — Computerised Systems | Aligned | Audit trail, determinism, access control built-in |
| 21 CFR Part 11 — Electronic Records | Aligned | Tamper evidence via output hashing, signed audit logs |
| GAMP 5 — Software Category 4 | Configured Product | Configuration only, no custom code at customer site |
| ICH M7 (R2) — Mutagenic Impurity | Dedicated Tools | covatox_assess_ichm7_batch + expert review workflow |
| ICH Q1A/E — Stability | Dedicated Tools | covastab Arrhenius, shelf-life estimation with 95% CI |
| ICH Q12 — Lifecycle Management | Readiness | Versioning + change control pathways documented |
What 'Aligned' actually means here
Three measurable properties, not a marketing label:
Determinism
Tool versions are pinned. Identical input → identical output, reproducible weeks later. No RNG seed drift, no LLM probabilism in the numerical path.
Audit Trail
Every tool call is logged with input, output, tool version, timestamp, and API key ID. Logs are exportable as CSV or JSON.
Tamper Evidence
Output includes a SHA-256 hash. If an audit log entry is modified post-hoc, re-hashing surfaces the change.
What validation means at CovaSyn
- Pro/Unlimited: Software delivers audit-grade outputs. Use-case validation happens at the customer site.
- Enterprise: Validation pack with URS, FS, IQ, OQ, PQ templates. GAMP 5 Cat 4 argumentation included.
- Validation IS what runs at the customer site. That's the regulatory reality — no software ships 'fully validated' at purchase.
What we do NOT claim
- 'GxP-validated' as out-of-the-box property. Validation is a customer process, not a vendor property.
- 'Replaces QA review'. CovaSyn complements QA workflows, does not replace them.
- 'FDA-approved'. Software is not FDA-approved — only devices and compounds are.
- 'SOC 2 Type II certified'. In preparation, not yet certified.
Need the validation pack?
Included in the Enterprise tier. Book a discovery call for a walkthrough.