PharmaQMS Global
A 21 CFR Part 11-ready, EU Annex 11-aligned, ALCOA+ driven eQMS/eDMS and data integrity platform for pharma QA, QC, R&D, CRO and CDMO teams.
Platform shortcuts
Jump into the areas you use most.
Controlled eDMS
Versioned SOPs, review, approval, lock, print control, and training linkage.
Maker-checker workflows
Configurable regulated workflows for deviation, CAPA, change control, and audits.
Part 11-ready controls
Unique user login, e-signatures, audit trails, session timeout, and lockout support.
QC and LIMS Lite
Sample tracking, test execution, COA generation, and stability study tracking.
Integration adapters
CSV, device, API, and instrument connectors with full traceability.
Program direction
Phase-led rollout with regulated controls first, then eDMS, quality events, and operational modules.
The scaffold is designed so every business table carries tenant context, lifecycle status, timestamps, and user attribution. Every critical action is auditable, every approval can require a re-authenticated e-signature, and every approved record is lockable.
The next implementation steps are already broken into platform foundation, document control, quality event management, and operational modules so we can ship in a controlled, validation-friendly sequence.
Validation posture
Built for inspection readiness, traceability, and controlled change.
Phase-based build plan
The phase plan is documented in docs/phase-plan.md and tracks features, tables, APIs, RBAC, tests, seeds, acceptance criteria, and deployment notes for each rollout stage.