The ValiTrail Workflow

From blank page to validated equipment.

Explore the 4-step journey that replaces chaotic email chains and scattered Word documents with a secure, traceable, and AI-assisted workflow.

1

Intelligent Drafting (The Setup)

Start a new User Requirements Specification (URS) by choosing from over 100+ GAMP 5 templates based on equipment type, or simply drag and drop your legacy PDF.

  • Instantly extract metadata from old PDFs
  • AI assistant drafts testable, measurable criteria
  • Structured mapping to GxP categories automatically
2

Internal Review (The QA Check)

Before sending your requirements to vendors, run them through ValiTrail's Compliance AI to flag weak acceptance criteria and ensure alignment with 21 CFR Part 11.

  • Automated checks against EU Annex 11
  • Section-based team assignments
  • Immutable audit trail of internal edits
3

Supplier Negotiation (The Handoff)

Stop sending version-controlled Excel files back and forth. Generate a secure, trackable link and invite suppliers directly into the platform to review requirements.

  • Real-time point-by-point vendor responses
  • Secure deviation management workflows
  • Zero email attachments required
4

Approval & Traceability (The Finish Line)

Once terms are negotiated, the final version is locked. Route the document for electronic signatures and let the system automatically build your Traceability Matrix.

  • 21 CFR Part 11 compliant E-Signatures
  • Fully automated Traceability Matrix generation
  • PDF exports with complete audit trails

Ready to start your journey?

Get a personalized walkthrough of the ValiTrail platform and see how much time your team can save.