FeaturesPricing
From Weeks to Minutes

Generate Validation Documents in Minutes. Execute Them with Full Traceability.

AI-powered validation document generation and digital execution for GMP-regulated equipment. Move from equipment specs to executed IOQ records in one controlled system.
Before
"More time formatting than actually validating."
"Approved it — then requirements didn't match the tests."
"Every equipment ends up with different documentation."
"Wouldn't feel confident walking an auditor through this."
Week 1Draft URS from scratch
Week 3Review cycle #4
Week 6Still waiting for RA signoff
After — With ValDoc
URS
RA
IOQ
SOP
UploadManual uploaded
ExtractEquipment fields auto-extracted
DraftURS, RA, IOQ, and SOP generated
ReviewApprovals routed with full revision history
ExecuteTest cases completed by subunit with e-signatures
EvidenceSupporting records attached to the execution
ResolveExceptional conditions reviewed and closed
CompileExecuted IOQ compiled with approvals and evidence
One Systemfrom first draft to executed IOQ record
Supports Part 11 Workflows
Built for GMP Teams
Full Audit Trail
Human-in-the-Loop AI
No Training on Your Data
Document Lifecycle

The Complete Validation Document Chain

One platform, one source of truth — every document linked and every requirement traced from URS through executed qualification.
URS
RA
IOQ
SOP
URS
User Requirements
Functional requirements
Performance specifications
RA
Risk Assessment
Hazard identification
FMEA analysis
IOQ
IOQ Protocol
Installation checks
Operational tests
SOP
Standard Operating Procedure
Step-by-step procedures
Maintenance schedules
See all features
70%Reduction in Validation Authoring Time
60+Spec Fields Extracted
<90sFirst Draft Generation
End-to-EndTraceability Through Execution
Digital Execution

Approved Protocols Become Executed Records

Generate the validation package in ValDoc, then carry the same controlled workflow through execution, evidence capture, exceptional conditions, and compiled closeout.
Execution
Execute by SubunitEach subunit runs in its own execution workspace so teams can work test case by test case without losing revision context.
Dedicated execution workspace per subunit
Guided progression across IQ and OQ activities
Execution status and completion visibility at every step
Evidence
Capture Evidence as You GoKeep signatures, linked records, and supporting evidence with the execution instead of scattered across drives and email threads.
Electronic signatures captured directly in the workflow
Required attachments linked to the relevant test cases
Supporting-record video uploads with unique record IDs
Exceptional Conditions
Keep Deviations StructuredFailures do not disappear into side conversations. They become linked exceptional conditions with a governed resolution path.
Fail results automatically create exceptional conditions
Five-step digital EC workflow from observation to verification
Two approval cycles before an EC is considered closed
Closeout
Compile the Final RecordWhen execution is complete, ValDoc turns the working record into an audit-ready executed IOQ package.
Execution review and approval in the platform
Compiled executed IOQ merges data, ECs, signatures, and evidence
Final record stored with the subunit for future review
One traceable path:
  1. Generate drafts
  2. Approve revisions
  3. Execute test cases
  4. Resolve exceptional conditions
  5. Compile the executed IOQ
Workflow

Five Steps from Specs to Executed Qualification

From equipment manual to compiled executed IOQ, the workflow stays in one GMP-focused system.
  1. 01
    GenerateAI generates URS, RA, IOQ, and SOP drafts from equipment specs inside controlled templates.
  2. 02
    EditRefine content with structured editing, comments, and revision-aware collaboration.
  3. 03
    ApproveRoute revisions through review and approval workflows before they move into execution.
  4. 04
    ExecuteRun the approved protocol by subunit, capture e-signatures, and attach supporting evidence as you go.
  5. 05
    Close & CompileResolve exceptional conditions, collect final approvals, and compile the executed IOQ record.
Trust & Transparency

AI You Can Trust in Regulated Environments

Built for GMP — not a general-purpose chatbot repurposed for compliance.
Human-in-the-Loop
AI generates document drafts. Subject Matter Experts (SMEs) review, edit, and approve every word before anything is finalized.
No Training on Your Data
Your equipment specs, documents, and validation data are never used to train our models. Your data stays yours.
Model-Agnostic
We're not locked to a single AI provider. We continuously evaluate and update to the best available models so you always get the strongest output.
Controlled Generation
AI operates within predefined validation templates and domain logic. No freeform hallucination — every output follows established GxP document structures.
Full Audit Trail
Every AI-generated output is tracked, versioned, and attributable. You always know what was generated, what was edited, and who approved it.
Domain-Trained, Not General Purpose
Our AI is tuned specifically for GxP validation workflows — not a generic model bolted onto compliance.
Questions about AI, data use, or review? Refer to our FAQ.
Coverage

Built for Every Equipment Family

Pre-configured templates for common GMP equipment — scale validation effortlessly across sites, teams, and equipment families.
Biosafety CabinetsBSC
Class II Type A2/B2 cabinets — airflow velocity, HEPA filter integrity, containment testing.
Controlled Temperature UnitsCTU
Refrigerators, freezers, ultra-low — temperature mapping, alarm verification, recovery time.
IncubatorsINC
CO₂, humidity, and temperature-controlled — uniformity studies, gas concentration, door recovery.
CentrifugesCEN
Micro to floor-standing — speed calibration, timer accuracy, imbalance detection.
Environmental MonitoringEMS
Particle counters, air samplers — sensor calibration, data integrity, alarm thresholds.
Thermal Sealing and Welding SystemsTSWS
Plate sealers, tube sealers, tube welders — seal integrity, uniformity, and reproducibility verification.
Weighing DevicesWDV
Micro, analytical, and precision balances — linearity, repeatability, eccentricity testing.
Liquid Handling EquipmentLHE
Manual and electronic pipettes — volume accuracy, precision, tip compatibility verification.
Cryogenic SystemsCRY
Ultra-low temperature storage — liquid nitrogen dewars, cryopreservation, viability maintenance.
Stability ChambersSTC
Temperature and humidity controlled — stability testing, long-term storage, ICH condition profiles.
Sterilization EquipmentSTE
Autoclaves, dry-heat sterilizers — cycle validation, biological indicators, load configuration.
Transport SystemsTRN
Cold chain shippers and containers — temperature maintenance, transit qualification, payload capacity.

Ready to Modernize Validation from Draft to Execution?

See how quality teams are replacing fragmented authoring, execution, and closeout workflows with one connected platform.