Covers the full quality system — deviations, CAPA, change control, complaints, and recall — built around ICH Q10 principles and inspection-ready at any point in time.

Every record creation, edit, approval, and rejection is timestamped and user-attributed. When an inspector asks — the answer is already there.

Log deviations, link root cause investigations, assign CAPA actions, and track effectiveness checks — all in a closed loop that prevents recurrence and satisfies FDA and EMA expectations.

Issue lab orders against registered specifications, capture results, flag out-of-spec findings, and generate Certificates of Analysis — without leaving the system.

Manage IQ/OQ/PQ lifecycle, calibration schedules with due-date alerts, and preventive maintenance — with automatic flagging when equipment falls out of qualified status.

SOPs, protocols, and batch records go through controlled issuance, periodic review triggers, approval workflows, and tracked print requests — nothing gets used without authorization.

Define stability protocols per ICH Q1A, schedule time-point testing, capture results, and detect out-of-trend conditions before they become out-of-spec failures.

Enforce segregation of duties for batch release, QA approval, and lab results. Supports electronic signature workflows aligned with 21 CFR Part 11 and EU Annex 11 requirements.

Initiate changes, assess impact across affected SOPs, equipment, and lab specifications, route for cross-functional approval, and link implementation evidence — all traceable in one record.

Track deviation trends, CAPA closure rates, change control cycle times, and batch disposition status. Built for QA review meetings and ready to support regulatory inspections.