The validation platform for complex life sciences
Enabling AI for the design and execution of complex validation protocols — with full auditable traceability from protocol drafting to QA sign-off.
Zero Defect Tolerance in Regulatory Standards
End-to-End Digital Validation Cycle
Controlled Document Fields
Dynamic templates, Word file import, and cell-level tolerance/limit mapping for strict data governance.
FMEA Risk Assessment
Failure Modes and Effects Analysis (FMEA) aligned with ICH Q9 principles and CPP tracking.
AI Regulatory Inspection
Automated compliance GAP evaluation against EU GMP Annex 15, Chapter 4, and FDA Part 11.
Cryptographic Audit Trail
Tamper-evident, sequential audit trail sealing every cell change with SHA-256 hash chains.
Engineering That Perfects Every Step
Explore every module from tabular data capture to cryptographic audit trail exports as dedicated showcases.
Protocol & Acceptance Criteria Management
Manage validation protocols as structured, versioned data tightly coupled to regulatory rules and acceptance criteria.
- Organize validation protocols and sample batches in hierarchical document trees.
- Define cell-level tolerance limits (Min: 5.3286 | Max: 5.7159) with real-time Out-of-Specification (OOS) red border alerts.
- Calculate Mean, Min, Max, and RSD (Relative Standard Deviation) statistics in real time.
- Unify operator data capture and QA approval lifecycles into a single auditable interface.
Automated Regulatory GAP Analysis
Cross-examine validation documentation against EudraLex Vol 4 Chapter 4, EU GMP Annex 15, and FDA 21 CFR Part 11 standards.
- Automatically identify missing approval gates, methodology gaps, and risk evaluation omissions.
- Generate structured compliance scores (GAP Score: 94/100) with precise article citations (§4.1, Annex 15 §5.2).
- Monitor Critical Process Parameters (CPP) and FMEA RPN risks aligned with ICH Q9 principles.
- Remediate compliance deficiencies prior to regulatory inspections.
Context-Aware Verified Document Q&A
Perform semantic retrieval (RAG) across proprietary validation templates, SOPs, and FMEA sheets with exact citations.
- Query filling weight tolerances, autoclave temperatures, and acceptance limits directly from approved SOPs.
- Inspect exact source document citations, page coordinates, and similarity scores (Score: 0.412) for every response.
- Zero-hallucination inference strictly constrained to your enterprise validation repository.
- Customer data is never used for foundation model training; processed in isolated tenant sessions.
Dynamic Template & Bulk Field Builder
Convert legacy Word and PDF validation protocols into dynamically controlled, cell-level data capture templates.
- Import Word documents and multi-select 40+ table cells to assign bulk tolerances and rules.
- Define lower limits (5.3286), upper limits (5.7159), and authorized roles (PRODUCTION_OPERATOR) per cell.
- Bind automatic calculation formulas (=AVG(), =RSD()) to eliminate human arithmetic mistakes.
- Deploy digital twins of paper validation sheets in minutes without custom coding.
Immutable Cryptographic Audit Trail
Seal every data mutation with UTC timestamps, user roles, IP origins, and SHA-256 digital signatures per 21 CFR Part 11.10(e).
- Every cell edit and signature is cryptographically linked to the preceding entry in a tamper-evident hash chain.
- Inspect change reasons, operator credentials, and model versions retroactively without ambiguity.
- Export complete audit trail ledgers as cryptographically signed PDF/A packages or raw JSON payloads.
- Present undeniable compliance proof to regulatory auditors in seconds.
Live Software Interface & Simulator
01. Protocol Data Entry & OOS
01. Protocol Data Entry & OOS
Cell-level data entry, real-time OOS (5.800 g) red border alerts, and automated RSD calculations.
02. AI Regulatory GAP Analysis
Scans protocols against EudraLex Vol 4 Chapter 4 and FDA Part 11 to output structured GAP analysis.
03. AI Document Q&A
Context-aware RAG assistant providing verified tolerance answers directly cited from your templates.
04. Template & Bulk Field Builder
Bulk table cell selector, lower/upper limits (5.3286 - 5.7159), and role authorization mapping.
05. Cryptographic Audit Trail
Immutable sequential audit log with user roles, LLM engine metadata, and raw JSON payload inspector.
Interactive Audit Trail Simulator
Trigger actions below to experience DigiVal’s in-browser cryptographic audit logging mechanics in real-time.
| Timestamp (UTC) | User / Role | Action | Entity | Cryptographic Hash (SHA-256) |
|---|---|---|---|---|
| 2026-08-14T09:15:22.104Z | ahmet.yilmaz OPERATOR | PROTOCOL_CREATED | ProtocolDraft DV-PV-2026-0010 | e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855 |
| 2026-08-14T09:20:45.312Z | merve.kaya ANALYST | VALUE_ENTRY 5.306 g (OOS) | ProtocolCell (R1C1) DV-PV-2026-0010 | 7a8f3312bc8910fedcba4567890123456789abcdef0123456789abcdef012345 |
Note: This simulator operates entirely in-browser, generates representative hashes and timestamps, and does not store data on a server.
Detailed Module Features
Protocol grids, formula automation, limit boundaries, and QA approval lifecycles.
21 CFR Part 11 Matrix
Requirement-control-evidence mapping and shared customer responsibility breakdown.
Security & Deployment
Managed GCP Cloud and isolated On-Premise enterprise data residency options.
Begin Digital Validation at Your Facility with DigiVal
Schedule a tailored technical consultation with our validation engineering team to explore DigiVal in your production workflow.