ValDoc.AI

The Validation Operating System

Integrated capabilities that take you from equipment onboarding to controlled document generation, digital execution, and audit-ready closeout — without spreadsheets, copy-paste, or disconnected systems.

Equipment

Equipment Management

Your equipment library — organized by family, model, and subunit, with detailed specs, manual uploads, and validation context in one place.

Equipment families with shared spec field templates

Thorough specification fields per model

Subunit tracking for complex equipment and parent/child execution

Manuals and source documents tied to the equipment record

Maintenance

Maintenance & Calibration Control

Track PM and calibration work against the same equipment records used for validation. Keep schedules, evidence, vendor context, and due-state visibility close to the asset.

PM and calibration plans assigned by subunit

Due-soon, overdue, snoozed, paused, and follow-up queues

Historical evidence and event attachments captured in-system

Password-verified finalization for maintenance event outcomes

Generation

Controlled Document Generation

Generate validation documents from equipment data inside controlled templates and domain-specific rules. ValDoc creates structured drafts instead of open-ended freeform content.

Full validation chain: URS, RA, IOQ, SOP

Controlled AI layer creates structured drafts

Documents tailor equipment specs and requirements automatically

Generation jobs track model, prompt version, prompt hash, and token use

Accuracy diffing compares generated drafts against reviewed content

Consistent output across your entire equipment portfolio

Collaboration

Editing & Collaboration

Refine generated documents with a rich editor. Inline commenting and threaded discussions keep review feedback anchored to the content it references.

Rich text editor with tables, headings, and formatting

Inline comments tied to specific text selections

Threaded discussions with resolution tracking

Real-time presence shows who is viewing a revision

Doc-level and section-level comment support

Execution

Digital Execution

Move approved IOQ protocols into execution workspaces built for real qualification activity. Test cases, signatures, evidence, and completion rules stay in the same governed system.

Dedicated execution workspace for each subunit

Guided test-case completion with phase-aware gating

Electronic signatures captured directly in the workflow

Attachment and supporting-record management tied to execution

Compiled executed IOQ output includes evidence and EC appendices

Exceptional Conditions

Structured Exceptional Conditions

When a test case fails, ValDoc creates a linked exceptional condition and routes it through a governed resolution workflow instead of leaving teams to manage it offline.

Fail results automatically create exceptional conditions

Five-step digital workflow from observation to verification

Two approval cycles before an EC is considered closed

Open ECs must be resolved before execution can be submitted

Approvals

Approvals & E-Signatures

Configurable review and approval routing across document revisions, execution review, and exceptional-condition closeout. Track who approved what, when, and why.

Multi-person review with configurable approval thresholds

Approval comments and decision capture across the workflow

Content hashes captured with signature and approval records

Stale approval detection when document content changes

Execution approval and rejection history captured in-system

Compliance

Audit Trail & Compliance

Every action tracked, every change logged. Designed to support Part 11-compliant use and keep both draft and executed validation records audit-ready.

Comprehensive audit log with actor, action, and timestamp

Filterable and exportable audit events

Hash-guarded revision saves reduce silent overwrite risk

Full revision history with immutable finalized versions

Compiled executed IOQ output with signatures, ECs, and evidence

Oversight

Visibility & Oversight

See your validation pipeline at a glance. Know which equipment needs attention, which documents or executions are in review, and what has already been finalized or compiled.

Pipeline visualization across URS, RA, IOQ, SOP, and execution

Models needing attention with next-action guidance

Maintenance queue highlights overdue, due-soon, and follow-up work

Personal queue for drafts, reviews, and approvals awaiting action

Recently finalized and compiled records feed

Ready to Streamline Your Validation Workflow?

Move from scattered documents and manual processes to an integrated validation platform built for GMP environments and executed qualification records.