21 CFR Part 11 Compliance with V5

Control. Traceability. Confidence.

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 secure electronic records, trustworthy digital signatures, immutable audit trails, and controlled system access across production, quality, and inventory. Whether you manufacture pharmaceuticals, medical devices, supplements, diagnostics, or combination products, V5 delivers the controls Part 11 expects—without slowing operations. It’s compliance by design, not by paperwork.

V5 unifies three core modules—MES, QMS, and WMS—so data is captured at the point of work and sealed into an audit-ready record set automatically. The same backbone supports complementary frameworks like EU Annex 11, GAMP 5, 21 CFR 210/211, ISO 13485, and device 21 CFR Part 820. If you need to show auditors a complete, clause-aligned story—from login controls and electronic signatures to record review and retention—V5 gives you evidence on demand.

“Before V5, we couldn’t prove who did what and when. Now our audit trail is irrefutable, signatures are tied to purpose, and reviews take minutes—not days.”
— Director of Quality, FDA-Regulated Manufacturer

Part 11 in Plain English—And How V5 Enforces It

Part 11 defines when the FDA will consider electronic records and electronic signatures “trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.” V5 operationalizes these expectations with controls that are enforced—not suggested:

Secure User Access: Role-based credentials, configurable password rules, account lockout, and optional multi-factor to harden access (see V5 Part 11 overview).
Electronic Signatures: Digital signoffs that capture user ID, timestamp, and meaning of signature (approve, verify, review) linked cryptographically to the record (see Annex 11 alignment).
Audit Trails: Immutable, time-stamped logs of creates/reads/edits/deletes, reason codes for changes, and full attribution across MES/QMS/WMS; exportable for inspections (eBR systems).
4-Eyes Governance: Dual control for critical activities (batch release, label issue, deviations)—covered in “4-Eyes” Part 11 governance.
System Validation: Risk-based validation lifecycle (IQ/OQ/UAT) with documentation packs per GAMP 5.

The outcome: records that withstand FDA scrutiny because controls are enforced by software, not by memory. V5 doesn’t just store data; it proves what happened, who did it, when, and why.

Electronic Records That Stand Up to Inspection

In Part 11 environments, every event that matters must be attributable, legible, contemporaneous, original, and accurate (ALCOA+). V5 captures and seals that evidence automatically:

Electronic Batch Records (eBR/eBMR): Step-by-step records are built as production runs—no after-the-fact transcription. Explore eBR and eBMR.
Deviation & Hold Logging: Exceptions capture who/what/why with linked CAPA in V5 QMS.
Training Checks: Access to critical tasks is gated by active training/certification; expired training blocks actions (see QMS).
Signature Purpose: Each signoff captures the meaning of the signature per FDA guidance (approve, verify, review)—see Part 11 controls.
Inspection-Ready Exports: Clause-tagged reports and complete audit trails on demand (how eBR systems work).

For device manufacturers, V5 also supports eDHR to meet ISO 13485 and 21 CFR 820 requirements, linking serial numbers, calibrations, inspections, and component lots directly to the device record.

“We passed our PAI without a single question on electronic records. V5 delivered exactly what the investigator asked for—instantly.”
— Compliance Lead, Contract Manufacturing Organization

Predicate Rules Still Rule—V5 Keeps Them Front and Center

FDA’s Part 11 Scope & Application guidance clarifies that Part 11 supplements predicate rules (e.g., 210/211 for drugs, 820 for devices) rather than replacing them. V5 implements this reality in two ways:

Hard-Gated Steps in MES: If the master record (MBR/MMR) requires a check—weight tolerance, blend time, in-process sample, label reconciliation—the next step simply won’t unlock until it’s done and signed (see eBR vs. paper).
4-Eyes & Reviews: For high-risk steps, V5 enforces dual approvals and QA review-by-exception; details in the 4-Eyes governance explainer.

The net is simple: Part 11 makes your digital records reliable; your predicate rules define what must be recorded. V5 makes both unavoidable.

Data Integrity by Default (ALCOA+)

Regulators expect proof that data is complete, consistent, enduring, and accurate. V5’s architecture helps you meet FDA’s data integrity expectations in practice:

Attributable: Every action is tied to a logged-in user; badge/2FA support is available (Part 11 controls).
Legible: Records are human-readable with full context—operator, lot, device, location, values (eBR systems).
Contemporaneous: Data is captured at the source in real time—no post-facto transcription (eBR explained).
Original: Source data and attachments (e.g., COAs, instrument files, photos) are preserved with versioning (CoA).
Accurate: Scale locks, barcode validation, tolerance bands, and device integrations reduce entry errors (Batch Weighing).

When auditors ask about data integrity controls, you won’t wave at SOPs; you’ll show enforced system behavior with a complete audit trail.

Validated, Scalable, and Documented—CSV Without the Drag

Computerized systems validation (CSV) doesn’t have to be a tax on your team. V5 aligns with GAMP 5 so you can execute a pragmatic, risk-based lifecycle (requirements → risk → IQ/OQ → UAT) with the right evidence, not mountains of paper. SG Systems provides validation materials and documentation, including a third-party Part 11/Annex 11 assessment you can reference during audits.

Where Part 11 Meets the Floor—MES, QMS, and WMS in Action

Part 11 controls only matter if they’re used in real work. V5 ties them into the places auditors actually look:

Production (MES): MES enforces step order, tolerances, monitored parameters, and signoffs at critical points. If the instruction says “±1.0%,” an out-of-tolerance addition gets blocked and escalated—no exceptions.
Quality (QMS): QMS governs documents, SOP acknowledgements, training, deviations, and CAPA. Changes to controlled documents require digital approval, and users must re-acknowledge new versions before access is restored.
Inventory (WMS): WMS enforces quarantine, holds, FEFO, allergen zoning, and label controls—all traceable to users and lots. It’s the same evidence base used for global traceability and recall drills.

Because these modules share one record spine, your e-signatures, audit trails, attachments, and CAPA links follow the work—not scattered across file shares.

Cross-Regime Confidence—Drugs, Devices, and Beyond

V5 is designed for multi-standard operations. If you’re in pharma, you’ll care about 21 CFR 210/211, Part 11, data integrity expectations, and CoA control. If you’re in devices, you’ll lean on eDHR, ISO 13485, and 820. If you’re a CMO/CDMO, you might need all of it, plus food/supplement controls. V5 handles the permutations:

Pharma: eBMR aligned to 210/211 with digital review-by-exception; CoA issuance tied to batch release (CoA).
Medical Devices: eDHR with serial/UDI linkages, training-to-access controls, and calibration interlocks (Medical Device Manufacturing).
Supplements / Cosmetics: Part 11 + MoCRA/111 and Annex 11 alignment; digitized label logic and allergen governance (digital vs. paper in supplements).

Same platform, different rulebooks—backed by the same enforceable signatures and audit trails under Part 11.

Records, Signatures, Copies, and Retention—No Loose Ends

FDA’s Part 11 Scope & Application and Data Integrity Q&A emphasize that firms must manage complete life cycles: creating, modifying, maintaining, archiving, retrieving, and transmitting electronic records. V5 covers these practicalities out of the box:

Record Copies: Human-readable and electronic copies are available; exports include signature context, meaning-of-signature, and timestamps (eBR systems).
Long-Term Retention: Retention and access controls are policy-driven; archived records remain retrievable for inspection.
Linkage: Signatures remain bound to their records; the linkage is part of the audit trail (see Part 11 page).

Common Failure Modes—And How V5 Avoids Them

Many Part 11 findings boil down to weak governance or system gaps. V5 closes those gaps by default:

Shared Accounts: Prohibited. Each signature maps to an individual credential (see Annex 11 access controls).
Uncontrolled Documents: QMS enforces versioning and acknowledgement; older SOPs can’t be used without explicit approval (QMS).
Backdating/Transcription: MES captures contemporaneous entries and stops progress if a required reading/signature is missing (eBR).
Single-Point Approvals: Critical steps require two-person checks—see 4-Eyes Rule.

From Paper to eBR/eDHR—Your Migration Path

Moving from binders to validated e-records is less painful than you think. A practical rollout looks like this:

Map Requirements: Identify which records and signatures fall under Part 11 for your products and markets (210/211, 820, Annex 11).
Harden High-Risk Steps: Start in MES with enforced tolerances, monitored CCPs/OPRPs, and electronic signoffs; generate eBR automatically.
Govern Documents & Training: Move SOPs and training to QMS with acknowledgement gates and training-to-access rules.
Lock Label & Warehouse Discipline: Enforce label issuance/reconciliation and quarantines/holds via WMS.
Validate & Prove: Execute a GAMP 5 validation plan (IQ/OQ/UAT) supported by SG Systems’ documentation and the independent assessment report.
Expand to eDHR (if device): Add device serial/UDI flows and test/inspection links in the eDHR model.

Each step increases inspection readiness and cuts paperwork load. When auditors arrive, you don’t compile evidence—you open it.

Business Case—Compliance That Pays Back

Part 11 is non-negotiable. But with V5, it’s also profitable. You’ll see fewer deviations, faster releases, cleaner audits, and lower Cost of Poor Quality. For the dollars-and-cents view, see “Say Goodbye to COPQ” and the platform-wide case in Global Batch Traceability.

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