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Kosha

Use case · Pharma & life sciences

GxP document control for pharma and life sciences

Regulators expect attributable, legible, contemporaneous, original and accurate records — and signatures that mean something.

The problem

  • Part 11 / Annex 11 signature requirements
  • Audit trails that must be complete and tamper-evident
  • Training evidence tied to effective SOPs
  • Validation effort for every system change

How Kosha helps

Electronic signatures

Re-authentication, signature meaning and a signature manifest on the rendered PDF.

  • Electronic signatures Enterprise

Tamper-evident audit

Hash-chained events with on-demand integrity verification.

  • Tamper-evident audit trail Starter+

Effective SOPs, acknowledged

Issue, read-and-understood, periodic review and records declaration.

  • Read & understood Business+
  • Periodic review Business+
  • Records declaration Enterprise

Recommended edition

Enterprise or Sovereign. Customers remain responsible for computer-system validation; configuration export supports change control between environments. See pricing

Speak your language

Rename Project → Product or Study, Approver → QA Approver.

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