Assure: the QMS record behind every product on market

What Assure holds

Assure is the quality management system: the full lifecycle of a deviation, nonconformance, CAPA, complaint, or change control, plus the surrounding record, structured root-cause analysis, risk register, audits, training, and stability.

A deviation or nonconformance cannot close without a complete root-cause analysis. An out-of-specification result runs ERRA's own two-phase investigation shape, modeled on FDA out-of-specification guidance: 21 CFR 111.87 requires the material review and disposition decision behind it, and 111.77 sets the rejection outcomes when a specification is not met.

What's in it

• Deviation, nonconformance, CAPA, complaint, and change-control lifecycle with CAPA effectiveness checks and supplier corrective-action requests.
• Structured root-cause analysis (5-Whys or 6M fishbone), required before a deviation or nonconformance can close, signed into the closure record.
• ERRA's own two-phase out-of-specification investigation, modeled on FDA OOS guidance, feeding the material review and disposition decision required by 21 CFR 111.87.
• Adverse event intake with reportability decision support and a MedWatch 3500A draft.
• A tokenized public consumer-intake endpoint that feeds straight into the QMS triage queue.
• Statistical process control trending, stability studies with advisory shelf-life projection, equipment calibration records, and controlled recall with consignee notification and reconciliation.
• Training curricula tied to role requirements, with signed self-attested completions.

Who reaches for it

Quality Assurance owns the QMS event lifecycle and the release-readiness picture it feeds. Compliance uses the same record to answer a regulator's question. Quality Control logs the testing and calibration evidence that feeds it.

Primary sources

• 21 CFR 111.87: material reviews and disposition decisions
• 21 CFR 111.77: what must you do if established specifications are not met

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