ERRA for Quality Control
The verdict you enter is the verdict the release gate reads. No second transcription, no drift.
What you do in ERRA
You receive a lot, transcribe the Certificate of Analysis against the ingredient specification, and record the release or reject decision. You perform in-process checks and batch tests during production, and where you are the verifier, the system enforces that you were not also the one who performed the step.
You determine skip-lot eligibility where it applies, with identity testing never skippable, and you log calibration and equipment records that feed advisory warnings against a batch.
What ERRA gives you
- Structured CoA transcription against the ingredient specification, with a deterministic pass or fail verdict.
- Skip-lot eligibility computed under 21 CFR 111.75, with identity testing always required.
- Second-person verification enforced through separate verify and production permissions, not a checkbox someone can skip.
- In-process checks and batch tests tied to the specific batch record, feeding directly into the QA release gate.
- Equipment and calibration records under 21 CFR 111.27, with advisory out-of-calibration warnings on affected batches.
- Statistical process control trending on assay series.
Where your work lands
The verdict you enter on a CoA or an in-process check is the same verdict Quality Assurance sees at the release gate. There is no second transcription step where your result could drift from what gets signed off.
Primary sources
Keep reading
Continuous attestation starts with a record that can be checked.
They check the sample. We attest to the system.