Compliance Management
Pharma quality compliance is a connected system where deviations lead to investigations, CAPAs, changes, and retraining. When managed in end-point systems, links become manual and inconsistent.
Deviation Intake and Investigation
Structured deviation intake form
Deviations are logged through a structured form that records type, severity, and scope, with required fields ensuring each record supports a proper investigation.
Assigned investigation with due date tracking
Each deviation is assigned to an investigator with a due date and tracked in the quality dashboard, making overdue investigations visible before they become inspection issues.
Root cause analysis with methodology support
The investigation workflow provides structured root cause analysis (Ishikawa, 5 Why, Fault tree) with the method documented in the record alongside the identified cause.
CAPA Management and Effectiveness Checks
CAPA action plan with owner and due date
Each CAPA includes a structured plan with action owners, due dates, and completion checks, making accountability clear and visible to quality management.
Effectiveness check scheduling
A scheduled effectiveness check, after CAPA implementation verifies results and automatically reopens the record if the corrective action fails to fix the root cause.
CAPA to deviation linkage
CAPAs link directly to their originating deviations, allowing two-way navigation between events and corrective actions, meeting FDA and EMA closed-loop quality audit standards.
Change Control Workflow
Multi-functional review and approval routing
Change requests are automatically routed to impacted functions (QA, regulatory, manufacturing, process dev, supply chain with configurable approvals) enforcing your quality system’s review rules.
Impact assessment documentation
Change control records include a structured impact assessment covering GMP, regulatory validation, and supply chain effects documented before approval.
Implementation and verification tracking
Post-approval changes are tracked in the change control record, requiring verification that each change was implemented as described before closing the record.