Validated templates
Take a CSV of an existing paper form and turn it into a digital template. Field types (numeric, date, text, locked), validation rules, and version control are part of it.
Double-blind verification
Two operators enter the same data without seeing each other's values. The system flags disagreements and a third reviewer decides which value is correct.
Role-based access
Admin, Submitter, Reviewer, and Read-only roles per engagement. External partners receive an email invitation scoped to the templates and roles you assign them.
Audit trail
Every submission, correction, export, and login is logged with the user, timestamp, and reason. Originals are never deleted.
Tamper-evident exports
Export records as PDF, CSV, or JSON. PDFs include a SHA-256 hash so the file's integrity can be verified. Bulk exports are delivered as a ZIP.
Corrections and versioning
Authorized users can correct submitted data. Each correction creates a new version (v1, v2, v3) with the diff visible. The original record is preserved.
Multi-organization engagements
Run data collection across multiple CMO and CLO partners from one workspace. Track the status of each engagement from a single view.
21 CFR Part 11
Designed around the FDA's rule for electronic records and signatures. The audit trail, e-signatures, and access controls are part of the platform, not optional add-ons.
See it on your batches
Thirty minutes with our team. We will walk through GXP Share against a real batch.
Book a demo