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FLAGSHIP QUALITY HISTORY REVIEW

CAPA Historical
Evidence Review

Start with what your organisation already knows.

Find potentially related quality issues, previous actions and evidence gaps, then record the named reviewer's judgement before export.

ApprovalSource lineageRead-only start
CONTROLLED CAPA WORKFLOWHUMAN IN CONTROL
NEW QUALITY EVENTCNC dimensional varianceNCR-2026-0148
CAPA
INTELLIGENCE
SIMILAR EVENTS6source-linked
EVIDENCE COVERAGE82%3 gaps flagged
DRAFT STATUSReadyfor investigator review
1
REQUIRED NEXT STEPInvestigator review and approval
REDUCEInvestigation administration
IMPROVEEvidence coverage and consistency
REVEALSimilar events and recurrence
RETAINHuman accountability
THE CUSTOMER PROBLEM

CAPA teams do not need
another blank form.

They need the relevant history, evidence and controlled documents brought together before scarce engineering time is lost searching for them.

01

History stays fragmented

Similar events sit across NCRs, complaints, audits and shared folders under inconsistent language.

02

Evidence varies by investigator

Preparation quality depends on experience, memory and the time available to search.

03

Administration delays action

CAPAs remain open while engineers reconstruct context that already exists somewhere in the business.

THE CONTROLLED WORKFLOW

From quality event to
review-ready investigation.

RepeatProof CAPA supports the preparation work around an investigation. It does not declare root cause, approve disposition or close the CAPA.

01

Structure the event

Normalise the problem description and identify the affected product, process, supplier, equipment and site.

02

Retrieve relevant history

Find similar NCRs, complaints, audit findings, previous CAPAs and controlled documents.

03

Expose evidence gaps

Create an investigation plan and show which records, checks or interviews are still required.

04

Prepare the draft

Draft the problem statement, containment summary and testable hypotheses with every source attached.

05

Route for approval

The named investigator edits, approves and exports the controlled output to the existing QMS.

CUSTOMER DELIVERABLES

Useful outputs.
Visible evidence.

Every engagement is designed around an agreed system of record and a named approval point.

01

Similar-event evidence pack

Relevant historical events, recurrence links and previous corrective actions with direct source references.

02

Investigation preparation pack

A structured problem statement, evidence request list and investigation plan for accountable review.

03

Controlled draft support

Containment and corrective-action drafting assistance clearly separated from authorised decisions.

04

Value and governance report

Measured improvement against baseline, user acceptance, source lineage and the production recommendation.

FIXED-SCOPE VALUE PROOF

The 4–6 week
CAPA Historical Evidence Pilot.

One site. One CAPA or NCR workflow. 250–1,000 approved historical records. Three to five named users. A bounded engagement with a clear decision at the end.

Week 1

Baseline and controls

Confirm scope, success measures, approved history, accountable owners and review gates.

Week 2

History preparation

Map 250–1,000 approved records into the controlled evidence structure.

Weeks 3–4

Retrieval and named review

Configure related-history retrieval, show why records surfaced and capture accept, maybe or reject decisions.

Week 5

Refine and verify

Confirm evidence lineage, limitations, reviewer rework and the agreed baseline comparison.

Week 6

Outcome and next decision

Deliver the reviewed evidence, evaluation pack and proceed, change-scope or stop recommendation.

Included in the pilot

  • Baseline and measurable value hypothesis
  • Representative historical sample
  • Similar-event retrieval and evidence-gap workflow
  • Source lineage and approval controls
  • User testing, training and operating guide
  • Final verified improvement report

Deliberately outside the pilot

  • Autonomous root-cause or disposition decisions
  • Automatic CAPA closure or product release
  • Replacement of the customer's QMS
  • Multi-site or enterprise-wide rollout
  • Unscoped data migration or systems integration
  • Claims of compliance or certification
VALUE PROOF

Success is agreed
before configuration.

The pilot compares the controlled workflow with the customer's current baseline. No vague claims and no value declared without customer verification.

  1. 01Investigation preparation hours per event
  2. 02Median investigation and CAPA cycle time
  3. 03Evidence completeness and reviewer rework
  4. 04Similar-event retrieval acceptance rate
  5. 05Recurrence visibility after corrective action
Q+
GOVERNANCE BOUNDARY

Evidence supports judgement.
People remain accountable.

RepeatProof may retrieve history, flag evidence gaps and suggest testable hypotheses. It never declares root cause, approves disposition, closes CAPA or releases product.

Customer-approved sourcesLeast-privilege accessPrompt and version controlsRecorded approval
THE BUYING JOURNEY

Diagnose. Prove.
Operate.

Begin with evidence, progress to a bounded CAPA pilot and move into managed production only when the value report supports it.

READINESS

Quality History Readiness Review

£1,500–£2,500

Five working days to test history, effort, data readiness and the strongest value case.

50% credited against a pilot commissioned within 30 days.
FLAGSHIP

CAPA Historical Evidence Pilot

£6,500–£9,500

Four to six weeks, one site, 250–1,000 records and three to five users.

Fixed scope. Prices exclude VAT.
MANAGED

RepeatProof Core

From £1,250/month

One proven historical-evidence workflow with monitoring, support and a monthly value review.

Available after a successful pilot.
START WITH YOUR CAPA WORKLOAD

Is there enough value
for a controlled pilot?

Submit your details and we’ll review the use case against urgency, measurable workload, available data and the governance boundary before contacting you to arrange a suitable discussion.

No platform pitchConfidential discussionClear next-step recommendation

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