Records in scope
- Complaint and vigilance references
- Nonconformance and investigation records
- CAPA and effectiveness evidence
- Product, process and risk references
LEFTFOUNDING MANUFACTURER PROGRAMMEProof Sprint · £2,950–£4,500
MEDICAL-DEVICE QUALITY HISTORY
Prepare complaint and CAPA history for governed human review.
An evidence-preparation path for teams that need traceability, cautious language and an explicit separation between retrieval support and regulated decisions.
View all industry examples ↗DATA STATUSIllustrative onlyQMS STATUSAuthoritativeCUSTOMER OUTCOMENot claimedQUALITY DECISIONSHuman-owned
Illustrative workflow — not customer data or a customer result.
This scenario describes a possible workflow using no customer records. Terminology, obligations and approval authorities must be checked against the manufacturer's products, markets and controlled procedures.
THE SITUATION
A recognisable starting point.
Not a promised result.
A complaint describes a failure that may resemble an earlier CAPA, but terminology and product references differ. The investigator needs a traceable shortlist without the software declaring causality or reportability.
What the team needs to know
Which approved historical records warrant human review, and which missing fields or evidence prevent a stronger conclusion?
What RepeatProof can prepare
- Potentially related records with source references
- Confidence and limitation statements
- Previous action and available effectiveness evidence
- Named human review decisions and export record
Decision boundary
RepeatProof does not determine reportability, patient risk, regulatory action, product release, root cause or CAPA effectiveness. Qualified, authorised people make those decisions within the approved QMS.
CONTROLLED PATH
From approved export
to governed handback.
Each stage has an owner and a visible boundary. Exact fields, systems, permissions and retention are agreed before data is exchanged.
Confirm the question
A named quality owner defines the current issue, records in scope and decisions that remain outside RepeatProof.
Check data readiness
Required fields, record counts, date coverage, missing values and source ownership are checked before analysis.
Prepare related history
Versioned rules surface potentially related records with source references, match reasons, confidence and limitations.
Review and hand back
An authorised person records Accept, Maybe or Reject and returns the approved evidence pack to the controlled customer process.
Confirm your real
workflow boundary.
The assessment checks whether your history is suitable and identifies the smallest credible first proof. It does not require a live QMS integration.