21 CFR Part 11 Compliance with V5 – Secure Records & Digital Signatures
V5 from SG Systems Global enables regulated manufacturers to comply with 21 CFR Part 11 by enforcing electronic records, digital signatures, audit trails, and controlled system access. Whether you’re operating in pharmaceuticals, medical devices, supplements, or diagnostics, V5 delivers full compliance—without compromising operational speed.
With integrated MES, WMS, and QMS modules, V5 turns recordkeeping and signature enforcement into part of your workflow—capturing data the moment it happens, verifying it, and locking it into an FDA-compliant audit trail.
“Before V5, we couldn’t prove who did what and when. Now our audit trail is irrefutable.”
— Director of Quality, FDA-Regulated Manufacturer
Built-In Controls for Part 11 Compliance
21 CFR Part 11 focuses on the trustworthiness and reliability of electronic records and signatures. V5 enforces these principles by design—not as an afterthought:
- Secure User Access: Role-based login with password aging, expiry, and automatic lockout
- Electronic Signatures: Digital approvals with user ID, timestamp, and reason-for-signature capture
- System Validation: Version-controlled processes, change control logs, and documented system validation
- Audit Trails: Time-stamped logs of every user action, modification, and approval—read-only and tamper-proof
- 4-Eyes Review: Dual signoff workflows for QA, supervisors, and batch release gates
Electronic Records that Stand Up to FDA Inspection
V5 ensures every critical process step, material movement, and signature is digitally captured and permanently recorded—removing ambiguity and eliminating paper risk:
- Step-by-step Electronic Batch Records (EBRs) with real-time signoffs
- Deviation, hold, and exception logging tied to user and timestamp
- Training and role validation before allowing action
- Signature reason and purpose fields to meet FDA intent
- Full audit log available for export in inspection-ready format
Every product batch, test result, and release decision is traceable to the person, place, and process—backed by system-enforced controls and digital validation.
“We passed our PAI without question on electronic records. V5 gave us the evidence they wanted—instantly.”
— Compliance Lead, Contract Manufacturing Organization
Enforced Compliance Without Slowing Production
V5 embeds 21 CFR Part 11 compliance into the production environment—without causing delays or extra steps. Compliance is not a bolt-on—it’s the core of how V5 works:
- Production: Electronic step enforcement, weighment verification, and signoffs at critical control points
- Quality: Automated checklists, exception handling, and CAPA management within V5 QMS
- Storage: QA hold enforcement, inventory quarantine, and reason-for-release capture
- Despatch: Final release authorization with digital signatures and timestamped chain of custody
Every person, process, and product is traceable—so when the FDA inspector arrives, there’s no scrambling to piece things together.
Validated, Scalable, and Fully Traceable
V5 is built for manufacturers who operate under strict regulatory oversight. Whether you’re in pharma, biotech, med devices, or supplements, V5 ensures your systems meet the FDA’s expectations for data integrity and process control:
- Deployed on-premise or cloud
- Integration with ERP, LIMS, printers, scales, and PLCs
- Supports compliance with 21 CFR Part 11, GAMP 5, EU Annex 11, and ISO 13485
- Validation documentation and test protocols available for regulated deployments
- Trusted by FDA-regulated manufacturers across pharma, medtech, and contract manufacturing
With V5, you get more than compliant software—you get a validated system that turns regulation into advantage.
Explore how each module supports 21 CFR Part 11 compliance:
