V5 for EU Annex 11 – GMP Compliance for Computerized Systems

V5 from SG Systems Global enables regulated manufacturers to comply with EU GMP Annex 11 by enforcing controls across data integrity, system validation, electronic records, and audit trails. From MES to QMS, V5 ensures computerized systems meet the strictest expectations of regulators. Validated. Compliant. Controlled.

Built for pharmaceutical, medical device, supplement, and cosmetics environments, V5 aligns Annex 11 clauses with digital infrastructure—providing transparency, documentation, and traceability throughout the lifecycle. Whether preparing for an EU inspector or strengthening your ICH Q10 quality system, V5 turns compliance into operational enforcement.

“With V5, Annex 11 wasn’t a checkbox—it was embedded in every workflow.”
— Quality Systems Manager, EU Pharma Facility

Background: Annex 11 and Global Alignment

Annex 11 is part of the EU GMP guidelines, setting expectations for computerized systems. It mirrors many requirements in FDA 21 CFR Part 11, and is supported by GAMP 5 validation frameworks. Together, these standards define how manufacturers must manage electronic records, data integrity, and digital validation. Failure to comply has led to warning letters, production suspensions, and product recalls across the EU.

Annex 11 covers every aspect of computerized system use: risk assessment, system validation, access control, audit trails, archiving, and business continuity. Unlike guidance documents, it carries legal weight. For global firms, harmonization between EU Annex 11 and U.S. FDA 21 CFR 210/211 is essential. V5 bridges both.

Annex 11 Clause-by-Clause with V5

Each Annex 11 clause is mapped in V5 with enforced controls:

• 1 – Risk Management: V5 applies risk-based controls to implementation and change management.
• 2 – Personnel: Enforced training certifications ensure only qualified users operate systems.
• 3 – Suppliers & Service Providers: V5 validation packages support supplier audits and integration oversight.
• 4 – Validation: IQ/OQ protocols plus UAT support full lifecycle validation.
• 5 – Data: Direct capture removes transcription risk, aligning with eBR requirements.
• 6 – Accuracy Checks: System logic prevents incorrect data entry and enforces formula enforcement.
• 7 – Audit Trails: Tamper-proof logs satisfy inspector expectations for traceability.
• 8 – Printouts: Controlled electronic reports with eDHR capability.
• 9 – Security: Role-based access plus two-factor authentication aligned with Part 11 four-eyes rule.
• 10 – Change Control: Logs capture who, when, why, and impact of each change.
• 11 – Periodic Evaluation: Scheduled reviews enforced through asset management and lifecycle audits.
• 12 – Electronic Signatures: Dual-authenticated signatures enforced with intent tracking.
• 13 – Batch Release: eBMR workflows enforce 4-eyes release review.
• 14 – Business Continuity: Redundant servers, backups, and controlled recovery plans.
• 15 – Archiving: Configurable retention, with encrypted recall.

Data Integrity by Design

V5 enforces ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate … plus Complete, Consistent, Enduring, Available). Examples include:

• Real-time traceability with enforced batch sequencing.
• No transcription risks—data flows directly from scales and batching systems.
• Deviation and CAPA escalations logged in QMS workflows.
• Secure archiving aligned with ISO 17025 lab competence.

System Validation & Change Control

System validation isn’t optional under Annex 11. V5 delivers:

• Installation Qualification (IQ) & Operational Qualification (OQ).
• User Acceptance Testing (UAT) in sandbox environments.
• Configurable compliance checklists for change control.
• Continuous validation through monitored updates.

This lifecycle approach satisfies GAMP 5 and inspector expectations.

Electronic Records & Digital Signatures

Annex 11 overlaps with 21 CFR Part 11. V5 enforces both:

• Unique credentials and 2FA for signatures.
• MMR, eBMR, and eDHR generation.
• Approval workflows with QA and production review.
• Version-controlled SOP enforcement with training links.

“We had zero findings in inspection thanks to V5’s validated infrastructure.”
— Regulatory Compliance Officer, EU Biotech Manufacturer

Cross-Standard Compliance Coverage

Annex 11 rarely stands alone. V5 enables unified compliance across frameworks:

• BRCGS, SQF, USDA FSIS for food.
• ISO 9001 and ISO 13485 for devices.
• 21 CFR 111 for supplements.
• MoCRA for cosmetics.
• FSMA 204 for food traceability.

Industry Applications

Each industry enforces Annex 11 differently:

• Bakery: allergen gates, allergen compliance, recipe enforcement.
• Meat & sausage: USDA HACCP with Annex 11 audit trails.
• Produce packing: FSMA 204 KDE/CTE capture.
• Plastics: validated batch traceability.
• Cosmetics: digital batch control.
• Supplements: digital vs paper batch records.
• Pharma: alignment with ICH Q7 API GMP.

Audit Readiness and Inspection Defense

Annex 11 demands evidence during inspections. V5 provides:

• Instant retrieval of batch records.
• Traceable Certificates of Analysis.
• Enforced quality gates at receiving.
• Automated waste reduction reports.

Inspectors see compliance hard-coded into the system, not just documented on paper.

Future-Proofing Annex 11 Compliance

Regulators expect continuous improvement. V5’s API connectivity future-proofs compliance by integrating with ERP (NetSuite, D365, Sage X3, QuickBooks, Dynamics GP), LIMS, and SCADA. This ensures Annex 11 remains enforced even as infrastructure evolves.

Conclusion

Annex 11 is a binding GMP requirement. V5 ensures compliance through validated, connected, enforced digital systems. By bridging eBMR, eDHR, MMR, and CoA within MES, QMS, WMS, and APIs, V5 turns Annex 11 from a compliance burden into a quality guarantee.