Built to pass 21 CFR Part 11, EU GMP Annex 11, and your next inspection.
Yuktra ships with a complete validation pack — IQ/OQ/PQ protocols, risk assessment, test evidence, and change-control procedures — so your QA team can validate in weeks, not months.
Every answer is cited, logged, and defensible.
Yuktra was built from the first line of code for 21 CFR Part 11, EU GMP Annex 11, and WHO-GMP environments. Source-grounded answers, tamper-evident audit logs, validated releases — not bolted on, baked in.
- 21 CFR Part 11 · EU GMP Annex 11
Electronic records & signatures, secure user binding, GAMP 5 Category 4 validation pack shipped with every deployment.
- Source-grounded answers — zero hallucination tolerance
Every response cites the SOP section, manual page, or precedent record it came from. If the corpus doesn't say it, Yuktra doesn't either.
- On-prem · air-gapped · your data never trains our models
Deploy in your VPC or fully offline. Role-based access mirrors your QMS. SSO, SCIM, customer-managed keys — standard.
- ISO 27001 · SOC 2 Type II
Independent security controls attestation. Annual penetration tests, quarterly vendor reviews, continuous control monitoring.
Make audit-readiness a daily default.
See a cited Yuktra answer on a real SOP — yours or ours — in 30 minutes.