Stop Managing CAPAs on Spreadsheets.
Most quality teams we speak with track corrective actions across email threads, shared drives, and paper registers. CAPAs stall, root cause investigations stay shallow, and auditors find gaps. Our CAPA module replaces that chaos with a structured digital workflow — configured around the way your team actually works.
CAPAs open for months create audit risk.
When a deviation occurs, the pressure to investigate, assign, and close the CAPA is real — but most quality teams don't have tools built for this. Excel trackers don't enforce deadlines. Emails don't create audit trails. Manual review cycles slow everything.
We built our CAPA module to give QA managers a single place where every action has a clear owner, a deadline, and a traceable history — from root cause through to effectiveness review.
No single system of record — actions tracked across multiple shared files
Effectiveness checks missed — no automated follow-up after closure
Root cause analysis documented informally and hard to retrieve during audits
No overdue alerts — managers learn about delays after the fact
Built around how QA actually operates.
Root Cause Investigation
Configurable RCA templates — Fishbone, 5-Why, or your own format. Every finding is recorded and linked to the source event for complete traceability.
Action Assignment & Deadlines
Assign CAs and PAs to individual owners with due dates. Automated reminders and manager escalations when actions approach overdue.
Effectiveness Review
The system prompts an effectiveness check after CAPA closure — a step commonly skipped in manual systems but required by quality standards.
Electronic Sign-Off
Every approval requires a PIN-verified e-signature. Signatures are timestamped and stored with the full audit trail — 21 CFR Part 11 compliant.
Live CAPA Dashboard
QA managers see all open CAPAs, statuses, owners, and deadlines in one view. No more manual status reports before management reviews.
Linked Deviation Records
Each CAPA is linked to its source deviation or complaint. Navigate between originating event and all related actions without leaving the system.
From event to closure — fully tracked.
Event Triggered
A deviation or audit finding is logged, categorized by severity, and routed to the responsible QA team member.
Root Cause Investigated
RCA is completed using the configured methodology. Evidence and documents are attached directly to the record.
Actions Assigned
Corrective and preventive actions are assigned to owners with deadlines. Automated reminders keep progress on track.
Reviewed & Closed
QA manager reviews and e-signs the CAPA. An effectiveness review is scheduled automatically after the defined period.
We're a startup building for the problem we've seen firsthand.
SQUETIKA is not an enterprise vendor with a decade of legacy software. We are a focused team that has worked inside pharmaceutical operations and understands why compliance tools fail in practice.
We configure this system to your existing SOPs and processes. Implementation is measured in weeks, not quarters. And we stay involved after go-live — because we know the real work starts there.
Talk to Our TeamReady to bring structure to your CAPA process?
Book a 30-minute walkthrough. We'll show you how the system works and how it maps to your current workflow.
Request a Walkthrough