ICH Q10 – Pharmaceutical Quality System with V5

V5 from SG Systems Global operationalizes ICH Q10 on the shop floor. No slide decks. No faith-based “we’ll catch it at review.” V5 hard-gates execution in-process, captures attributable electronic records with sealed audit trails, and ties your core quality processes—deviations, CAPA, change control, training, and document governance—directly to batch execution. The backbone is a tight integration of MES, QMS, and WMS. The outcome: a Pharmaceutical Quality System that stands up to FDA, EMA, MHRA, and PMDA scrutiny without slowing the line.

If you operate in pharma, medical devices, or dietary supplements, you already live under predicate rules and data-integrity expectations. V5 stitches those expectations into daily work: equipment with overdue calibration won’t run; operators without the right training can’t sign regulated steps; wrong-lot issues are blocked at scan; release decisions are supported by linked evidence. Electronic signatures meet 21 CFR Part 11 and EU Annex 11 requirements, with attributable, legible, contemporaneous, original, and accurate (ALCOA+) records that don’t buckle under inspection.

“ICH Q10 gave us the framework. V5 made it real—tying our quality system directly to batch execution, supplier controls, and training blocks.”

— Director of Quality, EU Solid-Dose Manufacturer

The ICH Q10 Core: Four Pillars, One Enforced System

ICH Q10 centers on: (1) Process Performance & Product Quality Monitoring, (2) Corrective and Preventive Action (CAPA), (3) Change Management, and (4) Management Review. Most sites “say” they do these. V5 makes them unavoidable, measurable, and reviewable—because they’re embedded in the systems that run your batches.

1) Process Performance & Product Quality Monitoring

In V5 MES, every critical parameter is captured with context: who performed the step, which device recorded the value, that device’s calibration status, the setpoint/limit, and the configured response when things drift. Think time–temperature holds, mixer torque, pH, conductivity, weight tolerances, sieve checks, metal detection, and vision/X-ray outcomes—logged against the batch with device identity and pass/fail logic. Fail a criterion? The system holds the process and alerts QA. No “we’ll fix the paperwork later.”

• Live SPC/trending: Process capability and drift detection by product, line, shift, and operator.
• Device intelligence: Results are signed with the device ID and calibration-at-time-of-use proof.
• Review by exception: QA looks at what matters; green-shift batches don’t waste review hours.

2) Corrective & Preventive Action (CAPA)

Deviations born in MES immediately generate quality events in QMS. Root cause tools (Ishikawa, 5-Whys) and tasking are integrated; effectiveness checks are scheduled up front. Because V5 links the CAPA to the originating batch, step, and material lots, you can prove the scope of impact, retest outcomes, and whether the fix stuck. If your industry is medical devices, CAPAs can be referenced in eDHR reviews; for supplements, CAPAs tie to Part 111 nonconformances; for pharma, batch release waits on closure when risk dictates.

• Immediate containment: WMS quarantine, MES holds, and customer blocks propagate instantly.
• Supplier-linked CAPA: Deviations at intake route to suppliers via approved-vendor profiles and COA failures.
• Audit-ready: Every action (who/when/why) is sealed with Part 11-compliant e-signatures and reasons.

3) Change Management

V5 treats change as a controlled workflow. MMRs, BOMs, SOPs, labels, and recipes are versioned, approved, and effective-dated in QMS; only those approved versions can be used in MES and WMS. If a label changes, that is the only label selectable on the line. If an SOP is revised, operators must read-and-acknowledge before they can execute the affected steps. That’s change control you can defend.

• Impact assessment: Proposed changes list affected products, lines, training, and supplier specs.
• Enforced rollout: Effective dates and training prerequisites block old versions at the point of use.
• Linked verification: Process validation steps and PQ/PV checks are tied to the change record.

4) Management Review

Management review is often a backward-looking PDF pack. V5 replaces that with live dashboards: quality events by severity, overdue CAPAs, audit-trail anomalies, batch success rates, first-pass yield, supplier defect trends, training compliance by role/area, and recall readiness metrics. When leadership asks “are we in control?”, you show data, not narratives.

• KPI rollups: Batch cycle time, deviation density, CAPA aging, change closure time.
• Drill-downs: From site → line → product → batch → record, including who-signed-what-when.
• Exportable evidence: Pack the review with the exact records inspectors will ask for.

Predicate Rules, Data Integrity, and Why Part 11/Annex 11 Aren’t Optional

ICH Q10 doesn’t replace predicate rules—it organizes them. V5 is built to enforce the details: cGMP expectations in 21 CFR 210/211, medical device QSR under 21 CFR 820 (reflected in our ISO 13485 content), and electronic records/signatures under Part 11 and Annex 11. Audit trails are immutable; e-signatures are attributable; role-based access, session controls, and reason codes prevent casual edits. Training and equipment status are evaluated at the time of action, not on a monthly spreadsheet.

• Training matrix locks: If allergen training or aseptic qualification expires, access to those steps is blocked.
• Calibration interlocks: If the probe verification fails, MES won’t accept new readings; the batch holds.
• Document control: Operators can only follow the currently effective procedure and label revision.

Lifecycle-Wide Control: Development → Tech Transfer → Commercial

ICH Q10 spans the product lifecycle; so does V5. During development, you establish the process and evidence of control. At tech transfer, you lock the MMR and device configurations, and you migrate validated parameters into production. In commercial, you scale across lines and sites with the same enforced logic. For combination products or device-centric environments, connect to eDHR requirements; for classic pharma, anchor to eBMR discipline. Either way, you’re not “documenting control”—you’re proving it as you run.

• Transfer packages: BOMs, steps, tolerances, label logic, and device settings move as a governed set.
• Scale-out consistency: New sites inherit the same rules; localizations are controlled changes, not tribal knowledge.
• Inspection continuity: The record of how you validated becomes part of how you operate—inspectors see the thread.

Material Governance & Warehousing That Doesn’t Blink

Most quality escapes start with materials: wrong lot, expired stock, mis-zoned allergens, or mislabeling at pack. V5 WMS removes luck from the equation. Intake checks, supplier status, COA capture, quarantine holds, FEFO putaway, location zoning, and scan-enforced issue controls are designed for regulated operations. If a component is on hold, operators cannot issue it. If a label version isn’t approved, it can’t be printed. If a pallet isn’t serialized to the order, it won’t ship.

• Supplier control: Approved vendors only; COA failures trigger holds and supplier CAPA.
• Allergen zoning: Segregation in storage and staged issue with scan checks at the line.
• Serialization: Pallets and cases matched to order/customer; shipping verification blocks mismatches.

People, Training, and Authorization—Gates, Not Guidelines

Competence is not a header in a policy; it’s a runtime decision. V5 QMS maps training to roles, areas, and tasks so that only the trained can execute or approve specific steps. When a procedure changes, everyone affected must re-acknowledge before the system lets them proceed. Supervisors and QA approvers are subject to the same rules. At audit time, “who signed and were they qualified?” is one click.

• Matrix enforcement: Role → competency → permission. Expired? Access denied.
• 4-Eyes built in: Dual-witness/approver steps enforced where your SOPs require them.
• Inspection evidence: Exportable training proofs and sign-off histories aligned to specific batches.

Label Governance & Pack Control—Where Many Audits Fail

Label errors are low-tech, high-pain. V5 treats labeling as a controlled manufacturing step. Templates are approved in QMS; selection in MES is gated by SKU and version; every print event is logged with batch, line, time, and operator. Retailer or country-specific variants are controlled selections, not operator memory. If your business also manufactures food or cosmetics, the same discipline extends to food and consumer product lines without duplicating effort.

• Approved templates only: Effective/expiry dating and full revision history.
• Code logic: Date/lot coding rules eliminate fat-finger risks at the line.
• Proof chain: “What was printed” is part of “what was shipped.” No ambiguity.

Continuous Improvement Isn’t Sloganeering—It’s Data You Can Defend

ICH Q10 calls for ongoing improvement. V5 makes it visible: defect paretos by product and supplier, deviation trends by line/shift, CAPA aging and recurrence, audit-trail exception rates, training compliance, right-first-time, and batch release lead times. For Pharmaceutical Manufacturing, that translates to fewer holds and faster Qualified Person decisions; for Medical Devices, cleaner eDHRs under ISO 13485/21 CFR 820; for Supplements, stronger Part 111 evidence with less administrative drag.

• Dashboards for leadership: One page to answer “Are we in control?”
• Drill to root cause: From KPI to the exact batch step and operator.
• Close the loop: Management review items become change/CAPA tasks with owners and dates.

Deploy on Your Terms—Validated, Documented, and Scalable

Cloud or on-prem, single site or multi-site, V5 is deployed with validation in mind. You get configuration specs, test evidence, and IQ/OQ-style documentation to support your validation strategy (GAMP-aligned). Integration via V5 Connect links your ERP (NetSuite, D365, GP, Sage X3, etc.), LIMS, printers, coders, scanners, and PLCs—so batch execution and quality control aren’t siloed tools but one operational system. Growth into adjacent verticals (e.g., Ag-Chem or Food Processing) reuses the same enforcement model with sector-specific tweaks, not net-new projects.

• Validated workflows: Documentation packs aligned to your VMP.
• Device/ERP/LIMS integration: Measurements, labels, lots, and orders flow without re-typing.
• Security & SSO: Role-based permissions, SSO, and data residency controls for IT and governance.

“We didn’t need more reports. We needed enforced behavior. V5 turned our QMS into the way the plant runs—ICH Q10, but executable.”

— Head of Manufacturing Science, US Biologics

What Inspectors Will See with V5

• Instant genealogy: Forward/backward trace with rework paths and mass balance.
• Proved controls: CCP checks, device verifications, labeling governance, and sanitation tasks—signed and time-stamped.
• Calibration & training at time-of-use: Proof that qualified people used qualified equipment.
• CAPA effectiveness: Trend reductions, recurrence checks, and linked change records.
• Document control: Current/effective SOPs and labels with approval signatures and revision history.

Modules That Power ICH Q10 Compliance

• MES – Enforced batch execution, device checks, timers, witnesses, and e-signatures (eBMR).
• QMS – Deviations→CAPA, complaints, training matrix, document control, change management, internal audits.
• WMS – Supplier status, intake inspections, FEFO/expiry, allergen zoning, quarantine, serialization, and pick/pack/ship verification.

Bottom line: ICH Q10 isn’t a certificate; it’s a way of working. V5 bakes that into your daily operations—so you don’t “prepare for audits,” you run to standard and let the system prove it. That’s consistent. That’s compliant. That’s controlled.