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.
01Equipment
01
Equipment
Equipment Management
Your equipment library — organized by family, with detailed specs and manual uploads. AI extracts specifications from uploaded manuals so you're not transcribing data by hand.
Equipment families with shared spec field templates
Thorough specification fields per model
AI-powered spec extraction from uploaded manuals
Subunit tracking for complex equipment
02
02Generation
02
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
Consistent output across your entire equipment portfolio
Drafts stay SME-reviewed and are never used to train models
03
03Collaboration
03
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
Doc-level and section-level comment support
04
04Execution
04
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
05
05Exceptional Conditions
05
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.
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
06
06Approvals
06
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
Stale approval detection when document content changes
Execution approval and rejection history captured in-system
07
07Compliance
07
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
Full revision history with immutable finalized versions
Compiled executed IOQ output with signatures, ECs, and evidence
08
08Oversight
08
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
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.