Deviations & CAPA
Stop putting out the same fires.
When a deviation occurs on the shop floor, the clock starts. QA Stack digitizes the entire event logging, root cause analysis (RCA), and CAPA initiation process so nothing falls through the cracks.
- Automated 5-Why and Fishbone RCA templates.
- Direct linkage from batch records to deviations.
- Enforced effectiveness checks before closure.
Change Control & Risk Register
Evaluate risk before you execute.
Whether you are updating an SOP, changing a supplier, or modifying equipment, QA Stack forces cross-functional impact assessments. The integrated Risk Register ensures ICH Q9 principles are applied automatically.
- Cross-departmental impact matrices.
- FMEA and standard risk scoring automation.
- Traceability from change request to implementation.
Out of Specification (OOS / OOT)
Defend your laboratory investigations.
OOS results are the #1 target for FDA 483 observations. QA Stack enforces strict Phase I and Phase II investigation protocols, preventing undocumented re-testing and ensuring proper batch disposition.
- Structured Phase 1 (Lab Error) checklisks.
- Phase 2 (Manufacturing) escalation paths.
- Integrated with LIMS and eBMR.
Audits & Training
Always audit-ready. Always qualified.
Manage internal, external, and supplier audits in a centralized hub. Automatically trigger training requirements when CAPAs or Change Controls result in new SOP revisions, ensuring shop floor operators are always qualified.
- Supplier qualification workflows.
- Automated read-and-understand quizzes.
- Real-time training matrix compliance dashboards.