Every approved phrase, one canonical source

Pharma teams manage critical language in Word files. When regulators ask for proof of approval, the trail breaks down. Proofbase is the content provenance engine that closes that gap.

21 CFR Part 11 Ready
FDA Compliant
Real-time Audit Trail
Multi-site Support
0%
Audit-ready traceability
0%
Faster label updates
0 min
To reconstruct approval chains

Trusted by pharma teams who can't afford to guess

When regulators demand proof, the answer is a click — not a two-week archaeology project.

14+ markets
Simultaneous label updates tracked
2-week → 2-hour
Submission archaeology eliminated
Zero findings
From content-provenance audits

Built for teams managing

Regulatory Affairs
Medical Information
Quality Operations
Label Management
CMC Documentation
Global Submissions

How Proofbase solves the provenance problem

The gap between how regulated pharma content is and how casually it's managed. We close it.

1

Canonical content layer

Every approved phrase lives in one source of truth. No more version archaeology across shared drives and email threads.

2

Deterministic generation

Labels and submission documents are generated from the canonical source — not assembled by hand. The output is always traceable.

3

Full audit provenance

Every change carries complete chain of custody: who approved it, what review it went through, what documents it touched.

This is not a QMS. This is not a document management system.

Proofbase is a content provenance engine for the specific problem of regulated language in pharma.

Purpose-built for regulated pharma text

The entry point is label updates. The moment the current system visibly fails is where Proofbase enters.

Label update workflow

Label update workflow

Track approved text changes across 14 markets simultaneously. Generate updated labels deterministically with full audit trail.

See it in action
Submission-ready outputs

Submission-ready outputs

Every document generated from the canonical library carries line-level traceability back to approved records.

See it in action
Approval chain reconstruction

Approval chain reconstruction

When the regulator asks, produce complete provenance: who approved it, what review it went through, what it touched.

See it in action

Pricing built for pharma budgets

Start with a 14-day free trial. No credit card required. Cancel anytime.

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All plans include baseline security, compliance logging, and quarterly training sessions. Enterprise plans can be customized for 21 CFR Part 11 validation requirements.

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