21 CFR Part 111 Compliance with V5 – GMP Control for Supplements
V5 from SG Systems Global helps dietary supplement manufacturers meet the strict GMP requirements of 21 CFR Part 111. From component control and MMR enforcement to production records and label verification, V5 digitizes every process step—ensuring traceability, accountability, and FDA audit readiness.
With integrated MES, WMS, and QMS modules, V5 transforms paper-based GMP systems into digital, enforceable, and reviewable records—so every batch is done right, every time.
“V5 gave us confidence in our Part 111 compliance—batch execution is controlled, and the records are bulletproof.”
— QA Manager, Nutraceutical Contract Manufacturer
GMP Enforcement Across Every Part 111 Subpart
21 CFR Part 111 compliance hinges on consistent execution and documented control across manufacturing, packaging, holding, and labeling. V5 makes these expectations enforceable—not optional:
- Subpart E – Component Control: Barcode-driven material intake with supplier approval, COA verification, and lot assignment
- Subpart F – Production & Process Control: Step-by-step MMR enforcement, electronic signoffs, in-process QA checks
- Subpart G – Packaging & Labeling: Label print control tied to batch, SKU, and version; rejection capture and escalation
- Subpart L – Holding & Distribution: FIFO pallet control, quarantine enforcement, and lot traceability in V5 WMS
- Subpart M – Records & Documentation: All actions digitally timestamped, signed, and retained per FDA requirements
Master Manufacturing Record (MMR) Control
V5 links every batch to a validated MMR, enforcing execution against target weights, sequencing, and required checks. Nothing is left to chance or operator memory:
- Step-by-step digital batch execution with required confirmations
- Actual vs target comparison with tolerance enforcement
- In-line checklists for line clearance, allergen control, cleaning verification
- Electronic signoffs with user ID, timestamp, and purpose
- Automatic lot tracking for all inputs and outputs
The result? Every Production Batch Record (PBR) is audit-ready, version-controlled, and validated against your approved MMR—down to the gram and second.
“We used to have binders full of scanned batch records. Now we have digital traceability from component to customer.”
— Director of Operations, Supplement Brand
Part 111 Compliance Without the Paperwork
V5 ensures every GMP requirement is followed, recorded, and retrievable—without slowing down production:
- Intake: Lot assignment, COA verification, supplier status check
- Blending & Weighing: Tare checks, batch yield variance tracking, real-time prompts for QA interventions
- Packaging: Label version control, in-process weight checks, allergen warnings
- Storage: Quarantine enforcement, QA holds, controlled release workflows
- Distribution: Full shipment traceability, product recall readiness
No handwritten records, no lost pages—just digital enforcement of what Part 111 demands.
Validated, Modular, Ready for Inspection
V5 is designed for contract manufacturers, private labelers, and vertically integrated supplement producers who need to prove GMP adherence daily—not just during audits:
- Runs on-premise or cloud
- Connects to ERP, LIMS, scales, printers, and PLCs
- Supports 21 CFR Part 111, 21 CFR Part 11, FSMA 204, and GFSI frameworks
- Full system validation documentation available
- Used globally by supplement brands, CMOs, and co-packers
Whether you make powders, capsules, liquids, or gummies, V5 helps you enforce Part 111 GMPs—at scale and without error.
Explore how each module supports 21 CFR Part 111 compliance:
