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Releases: leerogerstheman/LeebertyGXP

LeebertyGXP v1.0.0

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@leerogerstheman leerogerstheman released this 02 Oct 06:35

LeebertyGXP v1.0.0 - configuration-driven GxP compliance workbench (GMP / GLP / GCP / GVP / GDP / GPP).

  • Tamper-evident audit trail: append-only SQLite + SHA-256 hash chain + HMAC (key outside the DB), UPDATE/DELETE blocked by triggers.
  • Two-component e-signatures (21 CFR Part 11.200(a)(1)(i)) with single-use challenges.
  • 21 roles / 47 permissions; separation of duties enforced server-side.
  • 17 workflow definitions (deviation, CAPA, OOS, change control, documents, inspection, training, equipment, production batch execution) and 8 checklists (285 items).
  • Identity-first start-up with role-based landing; visibility by functional relationship; time-boxed external inspector with export auditing.
  • Native desktop window (WinForms + embedded WebView2); zero npm dependencies; runs offline.
  • 372 automated checks across 9 suites.

This is a technical demonstration / reference implementation, not a validated system. See README section 9 before use.