For pharma & food manufacturing · Kaltreon

Instrument drift on the production line — caught before the next batch release.

Continuous watch on HPLC, NIR, pH, conductivity, checkweighers, and metal detectors. When drift crosses your release threshold, you get a signed evidence packet mapped to BRC Issue 9, SQF Edition 9, and FSSC 22000 — not a spreadsheet the auditor has to chase the day before the audit.

The three-pillar loop

From the first deviation to a signed audit packet.

01

Catch instrument drift before the next batch release

Continuous watch on HPLC, NIR, conductivity, pH, weight-checkers, metal detectors, and checkweighers — between-shift, not at the next quarterly audit. When the drift crosses your release threshold, you get a deviation before the QC technician does.

  • Between-shift check, not calendar-driven
  • HPLC · NIR · pH · conductivity
  • In-process control thresholds

02

Map every drift event to BRC, SQF, and FSSC 22000

Each drift event, recalibration action, and post-event verification lands in a signed evidence packet — pre-mapped to BRC Issue 9 clause 4.10, SQF Edition 9 module 11, and FSSC 22000 additional requirement 2.5.3. Hand the auditor the packet, not the spreadsheet.

  • BRC Issue 9 clause 4.10
  • SQF Edition 9 module 11
  • FSSC 22000 AR 2.5.3
  • ISO 17025 calibration links

03

Close the loop with CAPA, OOS, and 21 CFR Part 11

A drift event opens a CAPA, a recalibration action closes it, and a signed verification packet seals the audit trail. Pharma lines get GAMP 5 validation hooks and 21 CFR Part 11 electronic-record integrity — without bolting on a separate compliance system.

  • GAMP 5 validation hooks
  • 21 CFR Part 11 audit trail
  • CAPA + OOS + lot release

Who this is for

Built for the QA, Validation, and Plant teams who own the CAPA queue.

Get early access

Be first in line when the manufacturing vertical opens.

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

Or read the deeper dive: Why instrument drift is the audit risk nobody is watching → · See the BRCGS compliance page →