Document control, deviation management, and change control — designed to support compliance with 21 CFR Part 11 and GxP requirements. No six-month implementation.
Your Part 11 compliance strategy is "we use DocuSign" and you know that won't survive an FDA inspection.
Batch records still involve printing, handwriting, scanning, and filing — a workflow from 1995 that nobody questions.
Computer system validation takes longer than building the system itself because the QMS has no built-in audit trail.
Deviation investigations reference SOPs that were updated three versions ago, and nobody caught it.
Change control for a one-line SOP update requires the same process as a major process change. Everything is a committee decision.
Not a generic QMS with a "pharma module" checkbox.
Electronic signatures with meaning, intent, and audit trail. Configurable sign-off reasons, dual authentication, and tamper-evident records — not just "e-signatures."
SOPs, batch records, protocols, and reports under version control with approval workflows. Periodic review reminders so nothing goes stale.
Link deviations to batch records, investigations, and CAPAs. Track root cause through effectiveness check with configurable workflows that match your process.
Risk-based change classification so minor changes don't require the same overhead as major ones. Impact assessments, approvals, and implementation tracking in one record.
Built with GxP in mind. Complete audit trail, access controls, and system documentation that simplifies your CSV effort instead of creating more work.
Manage supplier audits, quality agreements, and approved vendor lists. Risk-based re-evaluation schedules that run themselves.
Sign up in 30 seconds. No credit card. No sales call.
Start Free