Who we serve?

Clinical Research Organization

Leading CROs rely on us to take the complexity out of validation documentation, reduce manual work, and keep every deliverable audit-ready.

eClinical software providers

For eClinical software teams, we make validation easier to manage—bringing structured documentation, traceability, and human oversight into the development process.

Compliance & Governance

21 CFR Part 11 is about whether electronic records are trustworthy enough to replace paper and whether electronic signatures carry the same weight as handwritten ones. Validation Co-pilot is built around this principle, supporting GAMP-based validation, FDA Computer Software Assurance (CSA), and SaMD environments. The eleven-document chain it produces becomes the Part 11 record, governed by an approval state machine where nothing goes live without your say-so. A document becomes official only when your team approves it—never automatically.

Authorised access only
An audit trail you cannot edit
Signatures with real binding
Segregation of duties enforced in the database

Why choose Validation Co-Pilot?

Eleven documents, front to back — URS, VMP, Risk Assessment, Functional and Design Specifications, and the IQ / OQ / PQ protocols. Each one must trace cleanly to the one before it, preserving complete provenance and lineage across the validation chain.

Hand-drafted protocols eventually drift from the requirements they claim to verify, leaving reviewers to stitch together disconnected documents from different authors; and because auditors follow version history and signatures, a single gap can stall an entire release.

Validation Copilot generates the chain, links every document to the one before it, and hands it back to your team for review, signature, and approval.

What Validation Copilot does?

Sign with total confidence: every approval is bound to the person who made it, and the exact moment it was made and cannot be altered or retroactively disputed.