Our CAPA management service portfolio
Many teams stop at the action list. We take CAPAs through to a QA-ready closure: with a named cause, separated action types and an effectiveness criterion defined before implementation – not afterwards.
Entry point
Assessment & triage
First we establish whether the event warrants a CAPA or can be closed as a deviation with an immediate action. Risk, recurrence and regulatory relevance are documented before resources flow into root-cause work.
Outcome: justified CAPA decision with risk classification
- Deviation, OOS, audit finding or incident
- Immediate action vs. CAPA boundary
- Escalation to QA and management
Steering
Coordination in the quality system
We steer the CAPA in your QMS – TrackWise, Veeva Vault, SAP or paper-based. Owners, dates, approvals and communication with QA, the business and authorities stay traceably assigned.
Outcome: CAPA record with status, owners and milestones
- CAPA owner and review cycles
- Links to deviation and change records
- Authority communication prepared
Analysis
Root-cause analysis
We use 5 Why, Ishikawa and fault tree analysis – for IT incidents extended by log and audit trail review. The output is a named cause, not a list of suspicions.
Outcome: root-cause report with method, data basis and cause
- Interviews, process observation, system logs
- Symptom vs. cause separation
- Human factors and organisational drivers
Actions
Correction & prevention
Corrective actions remove the cause; preventive actions stop recurrence on comparable systems or sites. Immediate actions are tracked separately and not sold as CAPA closure.
Outcome: action plan with owner, date and type per action
- Technical, procedural and organisational measures
- Linked to change control and IT administration
- SOP updates and training where needed
Implementation
Implementation & evidence
We implement measures or guide your team: configuration changes, validation tests, process adjustments – always with evidence that lands in the CAPA record.
Outcome: implemented actions with test and approval evidence
- Change control and CSV updates
- Technical delivery by IT specialists
- Documentation ready for filing in the QMS
Closure
Effectiveness check & QA release
The effectiveness criterion is defined before implementation – not retrospectively. We verify that the cause was actually removed and prepare QA closure.
Outcome: CAPA closure report with effectiveness evidence
- Measurable effectiveness criterion
- Follow-up and trend review
- Lessons learned for comparable systems
What sets us apart: We know the difference between containing a symptom and removing a cause – and between CAPA and change control. That is why we close only when QA can stand behind the evidence.
Open CAPA or new finding?
Book an intro callCAPA guide
What is your starting point?
Choose your scenario – you receive the right entry route with references and contact path.
New deviation or OOS
Triage, root cause and action plan – before a deviation becomes an ageing CAPA backlog.
Inspection or audit finding
Structured CAPA after Form 483, warning letter or internal audit – with an evidence chain for QA and authorities.
Recurring incident
When the same disruption returns, the real root cause is usually missing – we go deeper than the last immediate action.
IT or laboratory system
CAPA on LIMS, CDS, MES or lab PCs: audit trail, configuration and process reviewed together.
Overloaded CAPA backlog
Prioritisation, PMO support and uniform templates – so genuine risks do not disappear in the backlog.
CAPA from a single source means one coordination from triage to QA closure – without handovers between analysis, IT implementation and validation.
Reference: CAPA after a critical GxP system deviation. Read the case story
Four action types – clearly separated
In audits, teams often collapse immediate action, correction and prevention. We keep the types cleanly apart – that is the core of robust CAPAs.
Immediate action
Contain the symptom and stop risk – without closing the CAPA prematurely.
Correction (CA)
Remove the cause: technical, procedural or organisational, with evidence.
Prevention (PA)
Stop recurrence on comparable systems, sites or processes.
Effectiveness
Define the criterion before implementation, then verify and close QA-ready.
Who is CAPA support for?
We work for QA, IT system owners and production management in GxP-regulated operations – on deviations affecting computerised systems, recurring laboratory incidents, or findings from inspections and internal audits.
When a CAPA list ages, the missing ingredient is usually capacity for root-cause work and follow-up – not goodwill. We relieve the pressure: one CAPA done properly, or a backlog worked through with structure.
Regulatory framework: EU GMP, ICH and FDA references
CAPA is part of the pharmaceutical quality system and is anchored in several regulations.
- EudraLex Volume 4, EU GMP Guide: Chapter 1 requires corrective and preventive actions including an assessment of their effectiveness.
- ICH Q10, Pharmaceutical Quality System: describes CAPA as a system in its own right alongside deviation and change management.
- 21 CFR Part 820: the medical device quality system regulation, where CAPA is a recurring source of observations.
CAPA and change control: two systems, one goal
CAPA clarifies cause and effectiveness. Change control approves the technical change. They interlock – they do not replace each other.
CAPA
- Root-cause analysis and action plan
- Correction and prevention
- Effectiveness check before closure
Change control
- Impact assessment on the validated system
- Approval, test and documentation of the change
- Closure of technical implementation
