For dietary supplement manufacturers operating under 21 CFR Part 111, this kit runs the cGMP batch recordkeeping the FDA inspects.
- It manages master manufacturing records, batch production records, incoming COA reconciliation, label-claim overage, and finished-product testing controls.
This kit is on the build list. Drop your email and we'll send it the day it ships — plus a
free quote calculator now. The most-requested industries get built first.
Planned modules
- Master manufacturing record and batch production record by lot
- Label-claim and active-ingredient overage calculator with assay tolerance
- Incoming raw-material COA and identity-test reconciliation log
- Blend uniformity, encapsulation/tableting yield, and reject tracker
- cGMP (21 CFR 111) deviation, CAPA, and quarantine/hold log
- Lot traceability, stability/expiration, and recall reconstruction sheet
Who it is for: 21 CFR Part 111 cGMP compliance, FDA facility registration, qualified QC/QA personnel, validated testing, and third-party (NSF/GMP) audit.
Planned pricing: starter $79 · pro manual $299 · updates $89/yr.