21 CFR Parts 210 & 211 Compliance with V5 – CGMP for Pharmaceutical Control
V5 from SG Systems Global helps pharmaceutical manufacturers meet the FDA’s Current Good Manufacturing Practice (CGMP) requirements outlined in 21 CFR Parts 210 and 211. From raw material control to packaging, labeling, and batch release, V5 enforces digital precision and complete traceability—ensuring compliance across every step of drug production.
With integrated MES, WMS, and QMS modules, V5 delivers enforceable CGMP processes, automated quality checks, and fully reviewable digital batch records that support drug safety, consistency, and FDA audit readiness.
“V5 brought structure and visibility to every CGMP requirement in 210 and 211—from blending to final release.”
— Head of Compliance, Solid Dosage Manufacturer
CGMP Enforcement Across Parts 210 & 211
V5 enforces the most critical sections of Parts 210 & 211 through digital workflows and traceable records. No gaps. No assumptions. No paper trails:
- 211.80 – Components, Containers, and Closures: Lot tracking, quarantine enforcement, and supplier approval at intake
- 211.100 – Production and Process Controls: Master Batch Record (MBR) enforcement, in-process controls, and deviation escalation
- 211.130 – Packaging and Labeling: Automated label print control, SKU-to-batch linking, and mislabel prevention in V5 WMS
- 211.192 – Batch Record Review: Step-by-step electronic records, digital signatures, and QA hold/release history
- 211.198 – Complaint Files: Integrated NCRs, CAPA escalation, and root cause analysis in V5 QMS
Master Batch Record Enforcement
V5 enforces execution against an approved Master Batch Record (MBR), ensuring every batch follows the validated recipe, weight tolerances, and QA checkpoints:
- Enforced sequencing of all steps with embedded operator prompts
- Tolerance checks for component addition, blending, and fill weights
- Electronic signoff with role-based access and reason-for-signature logging
- Deviation capture with escalation to QA for disposition
- Full traceability of inputs, yields, and process exceptions
The result: real-time enforcement of production controls and a complete digital record that mirrors your MBR—down to the lot, minute, and milligram.
“No more binders or post-batch cleanup. With V5, our records are built as the batch runs—and reviewed digitally in QA.”
— QA Director, Sterile Drug Manufacturer
Digital CGMP Without Disruption
V5 integrates Part 210/211 compliance directly into manufacturing operations—without slowing production or requiring separate systems:
- Weigh & Dispense: Material verification, tare enforcement, and auto-calculated actual vs target logging
- Processing: Batch step enforcement with in-process checks, blending logs, and hold points
- Packaging: Controlled label generation, print counts, rejection logging, and label version control
- Storage: QA hold enforcement, location control, and controlled release workflows
- Despatch: Audit-ready shipment traceability, with all products tied to digital batch history
No paperwork, no missed steps—just CGMP built into every batch run, label application, and warehouse movement.
Validated, FDA-Ready, Designed for Pharma
V5 is purpose-built for FDA-regulated manufacturers that need robust, scalable digital systems to support 21 CFR Part 210 and 211 compliance:
- On-premise or cloud deployment
- Validated against GAMP 5 with full documentation package available
- Supports 21 CFR Part 210, Part 211, Part 11, and global equivalents (EU Annex 11, PIC/S)
- Integration with ERP, LIMS, lab balances, barcode printers, and PLCs
- Used by drug manufacturers, CDMOs, and pharma packaging partners worldwide
Whether you produce oral solids, injectables, topicals, or combination products, V5 enforces every CGMP expectation—from receipt to release.
Explore how each module supports 21 CFR 210/211 compliance:
