Part 111 Software

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • 21 CFR Part 111 software, dietary supplement CGMP systems, MMR/BPR control, supplier quality, CAPA/deviations, traceability, audit trails • Dietary Supplements (USA)

Part 111 software is not one module you “turn on.” It’s the operational system (or system-of-systems) that makes your dietary supplement CGMP program repeatable, auditable, and scalable. In practice, Part 111 software is what prevents the classic supplement failure modes: uncontrolled master records, weak batch records, loose supplier documentation, slow release decisions, inconsistent investigations, and traceability that collapses into spreadsheets under pressure.

Many supplement companies can pass early-stage audits with paper and discipline. The breaking point arrives when SKU count grows, suppliers diversify, co-manufacturers appear, and shipment volume increases. At that point, your quality program either becomes governed by software controls—or it becomes governed by heroics (and heroics don’t scale). Good Part 111 software reduces cost and risk by enforcing the right controls at the right points: receiving, weigh/dispense, batch execution, quarantine/release, deviations/CAPA, complaints, and recall readiness.

“Part 111 isn’t about having documents. It’s about proving control when the business is moving fast.”

1) What supplement buyers mean by “Part 111 software”

When US supplement companies search for “Part 111 software,” they usually mean “software that helps us run a compliant operation without drowning in paperwork.” Typical drivers:

• We need controlled batch records that are consistent and audit-ready.
• We need supplier controls (COA verification and qualification) that scale.
• We need enforceable holds so unapproved lots can’t be used or shipped.
• We need faster release through structured evidence and review-by-exception.
• We need traceability that works quickly for mock recalls and supplier issues.
• We need consistent investigations and closed-loop corrective action.

2) Define success: Part 111 operational KPIs

3) What Part 111 software must cover (scope map)

Part 111 operations require multiple interconnected controls. At minimum:

• Master records MMR version control and effective-date enforcement
• Batch records eBPR/eBMR with exceptions and approvals (eBMR)
• Weigh/dispense scale integration, tolerances, lot verification (weigh/dispense control)
• Supplier quality qualification + COA verification (COA)
• Incoming inspection sampling rules and evidence capture (incoming inspection)
• Quarantine/release enforceable hold and disposition (material quarantine)
• Deviations/CAPA governed exceptions and corrective actions (deviation management, CAPA)
• Document control SOP/spec revision control (document control)
• Training role-based competency (training matrix)
• Complaint handling complaint trending and escalation (complaint trending)
• Traceability lot genealogy and recall readiness (lot genealogy)
• Integrity audit trails and signatures where used (audit trail, e-signatures)

4) Master records + batch records: the compliance spine

Part 111 operations are record-driven. Two record types matter most:

• Master instructions: controlled MMR that defines how the product should be made.
• Executed evidence: batch production records (BPR/eBPR/eBMR) showing how the batch was actually made (BPR conceptually).

Part 111 software must ensure the executed record is tied to the correct master version, and that deviations/overrides are captured as governed exceptions—not as handwriting or emails.

5) Supplier quality, COAs, and receiving controls

Most supplement quality problems start upstream. Part 111 software should control:

• Supplier qualification: enforce approved supplier status (supplier qualification).
• COA verification: required fields and spec match (COA).
• Incoming inspection: risk-based sampling and inspection depth.
• Quarantine and release: default quarantine until evidence is verified, with enforceable holds.

6) Execution control: weigh/dispense, steps, and hard gating

Execution is where compliance becomes real. Your system should enforce:

• Lot verification via barcode scanning before dispensing and consumption.
• Scale integration with tolerance enforcement (no manual weights).
• Step sequencing so critical checks can’t be skipped.
• Exception governance (overrides and deviations are structured and reviewable).
• Evidence capture feeding electronic batch review and BRBE.

That’s what enables faster release and less rework: the system prevents the most common errors instead of documenting them later.

7) Deviations, CAPA, change control, and training

Part 111 software must support consistent governance when things go wrong or change:

• Deviations: capture, containment, investigation (deviation management).
• CAPA: corrective and preventive actions with effectiveness checks (CAPA).
• Change control: governed master and SOP changes (change control).
• Training: ensure changes translate into competency (training matrix).

8) Complaints, trending, and post-market signals

Even supplement companies with low complaint volume need structured handling. Part 111 software should support:

• Structured complaint intake with lot linkage.
• Trending by SKU, lot, supplier, and defect category (complaint trending).
• Escalation triggers to investigations and CAPA when thresholds are hit.

9) Traceability and recall readiness

Traceability is how you limit recall scope and respond fast. Your system should support:

• Lot genealogy from supplier lots to finished lots (lot genealogy).
• Customer exposure lists for finished lots.
• Mock recall performance measurement (mock recall).
• Enforceable holds to stop exposure immediately.

10) The vendor demo script (copy/paste) + scorecard

Use this script to compare vendors fairly and expose gaps quickly.

11) Selection pitfalls (why Part 111 programs fail at scale)

• Buying a QMS-only tool. Part 111 needs execution and traceability controls, not just governance forms.
• Digital paper. If the system doesn’t enforce lot identity and tolerances, errors continue.
• No enforcement of holds. If quarantine doesn’t block, unverified lots will leak.
• COA as an attachment. Without verification logic, you’re accepting on trust.
• Exceptions outside the system. Email-based deviations and CAPA destroy closed-loop evidence.
• Traceability gaps. If you can’t produce exposure lists fast, recall scope and risk expand.

12) How this maps to V5 by SG Systems Global

V5 supports Part 111 operations by linking execution, warehouse controls, and quality governance into one evidence chain.

• Governance: V5 QMS supports deviations/CAPA, supplier quality, approvals, and audit-ready evidence.
• Execution evidence: V5 MES supports controlled batch execution, weigh/dispense, and electronic batch records.
• Warehouse enforcement: V5 WMS supports quarantine/hold/release enforcement and lot movement traceability.
• Integration layer: V5 Connect API supports ERP connectivity and structured exchange (API/CSV/XML).
• Platform overview: V5 solution overview.

13) Extended FAQ

Q1. What is 21 CFR Part 111?
It is the US CGMP regulation for dietary supplement manufacturing, covering how supplements should be produced, controlled, and documented.

Q2. Is Part 111 software just a QMS?
No. A QMS is important, but Part 111 compliance also depends on execution evidence: master/batch records, weigh/dispense, receiving/quarantine, and traceability controls.

Q3. What is the most important Part 111 control point?
For most supplement plants: controlled batch records tied to controlled masters, plus enforceable weigh/dispense and quarantine/release.

Q4. Do we need Part 11 electronic signatures?
Not always. But if electronic approvals replace handwritten approvals, you need governed e-signature behavior and strong audit trails.

Q5. What should we demand in vendor demos?
Proof of enforcement: holds block use, wrong lots are blocked, tolerances are enforced, deviations/CAPA are closed-loop, and genealogy/exposure reports can be produced quickly with exports.

Related Reading
• Regulation + Records: 21 CFR Part 111 | MMR | eBMR | BRBE
• Supplier + Receiving: Supplier Qualification | COA | Incoming Inspection | Material Quarantine
• Governance: Deviation Management | CAPA | Change Control | Complaint Trending
• Traceability + Proof: Lot Genealogy | Mock Recall | Audit Trail | Electronic Signatures
• V5 Products: V5 Solution Overview | V5 QMS | V5 MES | V5 WMS | V5 Connect API