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 your computerized systems meet the strictest expectations of regulatory authorities. Validated. Compliant. Controlled.

Built for pharmaceutical, biotech, and medical device environments, V5 aligns digital infrastructure with EU Annex 11 clauses—providing complete transparency, documentation, and traceability throughout the product lifecycle. Whether you’re preparing for a Notified Body inspection or strengthening your PQS framework, V5 transforms compliance from a documentation burden into a real-time enforcement system.

“With V5, Annex 11 wasn’t a checkbox—it was built into every step of our digital operation.”
— Quality Systems Manager, EU Pharma Facility

Annex 11 Clause Coverage

V5 aligns directly with the expectations of EU Annex 11, providing technical and procedural controls across every relevant section:

• 1 – Risk Management: Risk-based approach baked into implementation, change control, and record handling
• 4 – Personnel: Role-based system access, training record enforcement, and traceable user actions
• 7 – Validation: GAMP 5-aligned IQ/OQ with User Acceptance Testing (UAT) to satisfy operational qualification requirements
• 9 – Audit Trails: Secure, time-stamped, and unalterable logs for every critical event—fully searchable
• 12 – Electronic Signatures: Dual-authentication enforcement with traceable user credentials and signing intent
• 15 – Archiving: Configurable digital record retention with encrypted, redundant backups and recall access

From login controls to audit-readiness, V5 provides enforced digital systems that satisfy both EU Annex 11 and global GMP frameworks.

Data Integrity by Design

V5 enforces ALCOA+ principles—Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available—through every workflow and system interaction:

• All entries linked to users, roles, and time stamps
• Real-time data capture with system-enforced logic and validation rules
• No paper handoffs, no transcription risk—data is direct, structured, and locked
• Deviations, NCRs, and CAPA escalations are traceable and timestamped
• Secure storage with access control, backups, and configurable retention windows

Every system interaction is validated, logged, and protected. That’s data integrity enforced—not assumed.

System Validation & Change Control

V5 software is validated using GAMP 5 principles, supporting rapid deployment and ongoing compliance with Annex 11:

• IQ/OQ protocols provided for system installation and functional testing
• User Acceptance Testing (UAT) templates tailored to your operation—no separate PQ needed
• Sandbox environment allows validation and testing prior to production release
• Change control logs track every configuration change by user, date, reason, and outcome

Updates and enhancements can be implemented without compromising compliance—V5 ensures they’re properly tested, documented, and signed off before go-live.

Electronic Records & Digital Signatures

Electronic records in V5 are secured, attributed, and sealed to meet both Annex 11 and 21 CFR Part 11 standards:

• Each record signed using unique credentials and two-factor authentication
• Electronic batch records automatically generated from MES and QMS workflows
• 4-eyes approval workflows for production, quality, and release authorization
• Version-controlled documents and digital SOP enforcement across job roles

Every interaction is documented. Every signature is linked. Every record is sealed for traceability and regulatory confidence.

“We had zero findings in our GMP inspection thanks to V5’s electronic audit trails and validated infrastructure.”
— Regulatory Compliance Officer, Biotech Manufacturer

Explore the Full V5 Compliance Stack

V5 enforces Annex 11 compliance across every part of your manufacturing and quality ecosystem:

• Manufacturing Execution System (MES) – Digitized batch processing, job enforcement, and operator traceability
• Warehouse Management System (WMS) – Controlled materials handling with expiry, quarantine, and GMP status visibility
• Quality Management System (QMS) – CAPA workflows, audit management, deviation control, and electronic checklists
• V5 Connect API – Validated data exchange with ERP, LIMS, SCADA, and legacy systems

EU Annex 11 isn’t a suggestion—it’s a standard. V5 gives you the platform to meet it, defend it, and scale it without compromise.