BRCGS Issue 9 audit prep · Kaltreon

BRC Global Standard for Food Safety Issue 9 — clause 4.10 evidence, caught before the audit.

Continuous watch on HPLC, NIR, pH, conductivity, checkweighers, and metal detectors — the instruments auditors read under BRCGS Issue 9 Section 4 / clause 4.10. When drift crosses your release threshold, you get a signed evidence packet mapped to clause 4.10, not a spreadsheet the auditor has to chase the day before the audit.

The three-pillar loop

From the first clause 4.10 deviation to a signed audit packet.

01

Catch instrument drift between BRCGS Issue 9 calibrations

Continuous watch on HPLC, NIR, pH, conductivity, checkweighers, and metal detectors — between-shift, not on the calendar the auditor sees. When the drift crosses your release threshold, you get a deviation before the QC technician does, with the clause 4.10 evidence already attached.

  • Between-shift check, not calendar-only
  • HPLC · NIR · pH · conductivity
  • Checkweighers · metal detectors
  • Pharma: GAMP 5 validated hooks

02

Map every drift event to BRCGS Issue 9 Section 4

Each drift event, recalibration action, and post-event verification lands in a signed evidence packet — pre-mapped to BRC Global Standard for Food Safety Issue 9 clause 4.10 (calibration of measuring equipment), Section 4.1, and Section 1.1.1 management review. Hand the auditor the packet, not the spreadsheet.

  • BRCGS Issue 9 clause 4.10
  • BRCGS Section 4.1 documentation
  • BRCGS Section 1.1.1 management review
  • Pharma: 21 CFR Part 11 audit trail

03

Close the loop with CAPA, OOS, and audit-ready traceability

A drift event opens a CAPA, a recalibration action closes it, and a signed verification packet seals the audit trail. Food lines get clause 4.10 + ISO 17025 calibration links; pharma lines add GAMP 5 validation hooks and 21 CFR Part 11 electronic-record integrity — without bolting on a separate compliance system.

  • CAPA + OOS + lot release
  • ISO 17025 calibration traceability
  • GAMP 5 + 21 CFR Part 11 (pharma)
  • Signed packet, audit-on-demand

Who this is for

Built for the QA, Validation, and Plant teams prepping for BRCGS Issue 9.

Get early access

Be first in line when BRCGS Issue 9 evidence opens.

We're onboarding the first pharma and food-manufacturing customers for BRCGS Issue·9 clause 4.10 evidence now. Drop your work email and we'll route you to the right specialist — food safety, pharma QA, or plant operations.

Or read the deeper dive: Why instrument drift is the audit risk nobody is watching → · See the manufacturing vertical →