OqoVal
AI-driven CSV/CSA validation. Audit-ready from day one.
The validation engine that cuts up to 90% of GxP protocol drafting time, with electronic signatures compliant with 21 CFR Part 11 and EU Annex 11, and an immutable audit trail.
Traditional validation no longer scales with the business.
While GxP systems update every two weeks, validation programs still operate like in 2008. Cost, time and regulatory risk are climbing together.
Average increase in CSV validation cost across pharma IT projects over the last 5 years.
ISPE Pharma 4.0 benchmark
Weeks of average go-live delay caused by validation documentation.
OqoTech internal data 2023 – 2025
FDA inspections in 2024 issuing Form 483 for Computer System Validation deficiencies.
FDA inspection data 2024
Digital tools and intelligent systems used in GMP operations must demonstrate traceability, integrity and human oversight of every decision — including AI-assisted ones.
Three decades of regulation. One conclusion.
Every major regulatory shift was answered with more paperwork. AI changes the equation: evidence is generated, not drafted.
- 1997
21 CFR Part 11
Electronic records equivalent to paper. The era of mass documentation begins.
- 2008
GAMP 5
Risk-based approach. The industry learns to categorize but accumulates templates.
- 2022
FDA CSA
Computer Software Assurance. Stop documenting for the sake of it; prove the system works.
- 2025
EU Annex 22 + FDA AI Guidance
AI in GxP decisions. Traceability of algorithmic proposals and mandatory human oversight.
OqoVal on one page.
A SaaS platform that automates the full CSV/CSA validation cycle, from first draft to maintaining the validated state, with qualified people at the heart of every decision.
Generate
VP, URS, DQ, IQ, OQ, PQ, RA and TM from project context. Ready for review in hours.
Sign
Electronic signatures compliant with 21 CFR Part 11 and EU Annex 11, in a multi-level workflow.
Audit
Immutable audit trail, inspector-ready export and traceability of every AI-assisted decision.
Maintain
Change control with impact assessment and periodic review scheduled by GAMP risk.
Founding principle
AI proposes. Qualified people decide and sign. The system never approves nor validates autonomously.
Defensible ROI in year one.
Comparison based on industry benchmarks (ISPE GAMP 5 v2, FDA inspection data 2024 and OqoTech internal data 2023 – 2025). Actual results depend on scope and QA maturity.
| Metric | Traditional validation | With OqoVal | Reduction |
|---|---|---|---|
| IQ/OQ/PQ protocol drafting time per system | 40 – 80 h | 4 – 8 h | −85 to −90% |
| Validation cost per system (by complexity) | €20 – 150 k | €7 – 15 k (one-time) | −60 to −90% |
| Time-to-audit (inspection readiness) | 2 – 6 weeks | < 48 h | −95% |
| Periodic review report preparation per system | 2 – 4 days | < 2 h | −90% |
| Inconsistencies detected pre-inspection | Manual / sample | Automatic / 100% | — |
| Qualified team hours freed for expert judgment | — | 60 – 70% | + high value |
Indicative figures. Not a contractual guarantee. A detailed projection for your organization is delivered after a 30-minute technical session.
Designed against the frameworks that matter.
OqoVal complies by default with the four regulatory authorities that affect pharma industries in Europe, the Americas and Latin America.
Electronic records and signatures.
Computerised systems in GMP.
Risk-based validation.
AI in GMP operations.
OqoTech, OqoVal manufacturer, operates under certified QMS.
Data hosted in European data centers. Encryption at rest and in transit.
Every action logged with timestamp, user, reason and integrity hash.
By sector and system type.
Four customer profiles where OqoVal returns the highest value within the first 90 days.
Pharmaceutical industry
Multi-site manufacturers validating SAP, MES, LIMS and SCADA on a recurring basis.
Medical devices
Companies under MDR + FDA QSR integrating CSV into their QMS without doubling headcount.
Biotech and ATMP
Highly complex processes where data integrity is critical for batch release.
CROs and clinical units
Operators handling trial data under GCP needing to demonstrate Part 11 to sponsors.
Let's talk without a sales pitch.
A 30-minute conversation with OqoTech's CEO. No generic material: we review your current validation program and tell you honestly where OqoVal can help and where it cannot.