Solution · Source

Supplier qualification, scorecards, and CoA review

A qualification status that actually stops a purchase order, and a Certificate of Analysis that renders a verdict instead of a filed PDF.

What it does

A supplier's qualification status is enforced, not just displayed. A rejected, suspended, or expired qualification is a hard stop at purchase-order issue, with no override; a pending qualification is flagged rather than hidden, and can only be pushed past with the elevated override permission and a reason recorded in the audit trail.

Certificate of Analysis entry is structured, not a filed PDF: values are transcribed against the ingredient specification, and ERRA renders a deterministic pass or fail verdict, not a summary someone has to interpret.

What's in it

  • Supplier records with qualification workflow, expiry tracking, and a requalification window.
  • A derived scorecard, supplier dossier, and certificate document checklist.
  • Supplier-ingredient links with price history, minimum order quantity, pack size, and may-contain allergen facts.
  • Structured CoA transcription against the ingredient specification, with deterministic spec verdicts.
  • Skip-lot testing eligibility under 21 CFR 111.75, with identity testing never skippable.

Primary sources

Keep reading

Continuous attestation starts with a record that can be checked.

They check the sample. We attest to the system.