Module 03
Enterprise Quality
The closed loop your audits feed, on one record.
Events and investigation
- Deviations
- Detection, risk class, investigation, disposition — escalating to CAPA when systemic.
- CAPA
- Root cause, action plan, implementation, and effectiveness verified before closure.
- Complaints and OOS/OOT
- Intake, triage, investigation, and regulatory-reporting assessment.
Control and change
- Document control
- Authorship through retirement, with enforced version control.
- Change control
- Assessment and controlled implementation, linked to risk, validation and training.
- Training records
- Competency against roles, triggered by document revision.
Operations
- Batch records
- Disposition with the review and release gates it requires.
- Equipment
- Qualification state, calibration and maintenance, with expiry surveillance.
- Design control
- Design history and control for device-side programmes.
Oversight
- Risk register
- Identification through review, threaded across processes per ICH Q9.
- Management review
- The governance loop, with metrics aggregated from every module.
Underneath all of it
A configurable engine, not a pharma hard-code
The pipeline is fixed; standards, vocabulary and rules are data.
- Modules per tenant
- Turn modules on per customer; interface and permissions follow.
- Vocabulary per tenant
- Rename the domain objects to the customer's language without a fork.
- Standards registry
- Rules as data, evaluated deterministically by default.
- Part 11 throughout
- Enforced signature, immutable audit trail, ALCOA+ across every module.
Keep your eQMS, or replace it
Start where your current system is weakest and expand from there.