Intelligent automation for GxP validation
OqoVal automatically generates complete CSV/CSA documentation — VP, URS, IQ/OQ/PQ protocols, risk analyses, traceability matrices — audit-ready from day one.
“OqoVal is not a document editor. It is a validation engine that produces audit-ready GxP documentation, with valid electronic signatures under 21 CFR Part 11 and EU Annex 11, and an immutable audit trail.”
OqoVal in action
Real screenshots of the platform
Executive view with compliance KPIs, active projects, pending signatures and open deviations in real time.
Complete CSV documentation, AI-generated
Each lifecycle phase automatically generates its own deliverables from project context.
- Validation Master Plan (VP)
- User Requirements Specification (URS)
- Technical Specification (ET)
- Risk Analysis (AR)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Process Qualification (PQ)
- Validation Report (IV)
- Maintenance Manual (MX)
Controlled and immutable document workflow
Once IN_SIGNATURES status is reached, content is locked. New versions create an independent document and mark the previous one as OBSOLETE.
Everything you need for regulatory compliance
Automatic AI generation
Claude Sonnet generates each document in the complete CSV/CSA cycle from the project context. Each deliverable is directly usable in a real audit, without manual adaptations.
Electronic signatures 21 CFR Part 11
Sequential workflow Generator → Reviewer → Approver. Signature with personal PIN + OTP as second factor. Each signature includes SHA-256 hash, IP and timestamp. Compatible with external signatories via token.
Immutable audit trail (ALCOA++)
Automatic recording of every action: creation, modification, AI generation, signature, rejection. The audit table is write-only — no record can ever be modified or deleted.
Real-time traceability matrix
Automatically links URS → test cases → execution results. Calculated in real time from the database. Exportable to Excel in standard RTM format.
Risk analysis FMEA / ICH Q9
RPN scale according to ICH Q9 / GAMP5 (Severity × Probability × Detectability). Automatic risk generation from confirmed URS requirements. Table injected as Annex I in the Word file.
Regulatory library with RAG
Query GxP regulations using Retrieval Augmented Generation over GAMP 5, FDA, EMA, ISO 13485 and Annex 11. AI-powered search and automatic alerts for updates.
Deviation management
Standalone module to record and manage deviations and corrective/preventive actions (CAPA). Workflow: Open → Under Investigation → Under Review → Closed.
Granular RBAC access control
Configurable roles and permissions from administration without hardcoding. Three layers: global role, project access and role in the signature workflow. Client portal with limited visibility.
Architected for regulatory compliance
Every technical decision in OqoVal responds to a specific regulatory requirement.
- Electronic signatures with unique identification
- Immutable signature record with SHA-256 hash
- Complete audit trail with oldValue / newValue
- RBAC with secure authentication
- OqoVal itself generates its own validation documentation
- §4.5 – Complete IQ module (protocol / execution / report)
- §4.6 – Equivalent OQ module
- §4.7 – Equivalent PQ module
- System lifecycle management
- Single-use OTP with security cooldown
- AR module with RPN scale according to ICH Q9
- GampCategory field per computerized system
- URS → tests → results traceability
- AI record: model, tokens, status in AuditLog
- VP, URS, ET, AR, DQ, IQ, OQ, PQ, IV generated
- Attributable — every action linked to the user
- Legible — audit trail in interpretable format
- Contemporaneous — automatic timestamps
- Original — no possibility of deletion
- Accurate — immutable states once approved
Ready to eliminate documentation bureaucracy?
Request information and we'll explain how OqoVal can adapt to your regulated environment.
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