From Weeks to Minutes
Generate, Review, and Execute Validation Work. All in One Place.
Bring equipment specs, controlled AI drafting, SME review, digital execution, exceptional conditions, evidence, and compiled records into one GMP-focused workflow.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
EquipEquipment specs, subunits, and manuals organized
ExtractSource-backed fields suggested for review
DraftURS, RA, IOQ, and SOP generated from context
ReviewApprovals routed with hashes and 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
Source-Backed Extraction
Hash-Guarded Revisions
Password-Verified Signatures
Exportable Audit Trail
No Training on Your Data
Operating System
From Equipment Data to Executed Record
ValDoc keeps the regulated validation path in one governed system: equipment context, controlled drafts, review, execution, EC resolution, and final closeout.URS
RA
IOQ
SOP
- 01EquipStart from equipment families, subunits, manuals, specifications, maintenance plans, and calibration context.
- 02GenerateGenerate URS, RA, IOQ, and SOP drafts from controlled templates and equipment-specific source data.
- 03ReviewReview with threaded comments, live presence, approval thresholds, stale-approval detection, and content hashes.
- 04ExecuteRun the approved protocol by subunit, capture e-signatures, and attach supporting evidence as you go.
- 05CloseResolve ECs, approve execution, and compile the executed IOQ with signatures, ECs, and evidence indexes.
What Makes ValDoc Different
The Controls Behind the End-to-End Story
The visible product promise is simple. The value is in the governed mechanics that keep equipment data, AI output, reviews, execution, and closeout connected.Equipment
Equipment and subunit source of truthKeep models, subunits, specifications, manuals, supporting records, PM schedules, and calibration work connected before document generation starts.Family-specific spec templates
Subunit-level execution context
PM and calibration queues
Controlled AI
Source-backed drafting and extractionAI suggestions carry source evidence, page references, and review state so teams can inspect the basis for structured equipment data.Manual and spec-sheet extraction
Evidence support labels
Accuracy diffing after regeneration
Execution
Executed IOQ closeout in-systemApproved protocols move into digital execution, where test cases, signatures, ECs, attachments, and supporting records stay governed.Five-step EC workflow
Execution approval and rejection history
Compiled PDF with evidence index
Trust
Review controls buyers can inspectValDoc tracks review presence, content hashes, stale approvals, password-verified signatures, and exportable audit events across the workflow.Hash-guarded revision saves
Real-time revision presence
Exportable audit logs
Audit-ready path:
- Source evidence
- SME review
- Hash-guarded approval
- Digital execution
- Compiled evidence package
Equipment Coverage
Built Around GMP Equipment Families
Family-specific equipment context feeds specifications, generated documents, digital execution, and maintenance workflows across common GMP equipment types.- Biosafety Cabinets (BSC): Class II Type A2/B2 cabinets — airflow velocity, HEPA filter integrity, containment testing.
- Controlled Temperature Units (CTU): Refrigerators, freezers, ultra-low — temperature mapping, alarm verification, recovery time.
- Incubators (INC): CO₂, humidity, and temperature-controlled — uniformity studies, gas concentration, door recovery.
- Centrifuges (CEN): Micro to floor-standing — speed calibration, timer accuracy, imbalance detection.
- Environmental Monitoring (EMS): Particle counters, air samplers — sensor calibration, data integrity, alarm thresholds.
- Thermal Sealing and Welding Systems (TSWS): Plate sealers, tube sealers, tube welders — seal integrity, uniformity, and reproducibility verification.
- Weighing Devices (WDV): Micro, analytical, and precision balances — linearity, repeatability, eccentricity testing.
- Liquid Handling Equipment (LHE): Manual and electronic pipettes — volume accuracy, precision, tip compatibility verification.
- Cryogenic Systems (CRY): Ultra-low temperature storage — liquid nitrogen dewars, cryopreservation, viability maintenance.
- Stability Chambers (STC): Temperature and humidity controlled — stability testing, long-term storage, ICH condition profiles.
- Sterilization Equipment (STE): Autoclaves, dry-heat sterilizers — cycle validation, biological indicators, load configuration.
- Transport Systems (TRN): Cold chain shippers and containers — temperature maintenance, transit qualification, payload capacity.
- Label Printers (LPR): Label printers — print quality, barcode readability, label alignment, and traceability verification.
- Vacuum Pumps (VAC): Vacuum pumps — vacuum performance, pump-down time, leak rate, and gauge verification.