GAMP 5 Software Validation with V5 – Risk-Based Compliance for Regulated Systems
V5 from SG Systems Global helps regulated manufacturers meet GAMP 5 expectations by delivering a validated platform with full IQ, OQ, and support for UAT. Designed for use in FDA- and EU-regulated environments, V5 turns GAMP 5’s lifecycle and risk-based principles into enforceable digital systems with documented evidence of control and reliability.
Whether you’re in pharma, med devices, supplements, or food, V5 provides traceable manufacturing, quality, and inventory workflows that can be validated to GAMP 5 standards—with a full documentation pack available upon request.
“We validated V5 using the provided IQ/OQ documents and executed UAT onsite. Audit passed without a hitch.”
— CSV Lead, Global Contract Manufacturer
What GAMP 5 Validation Means with V5
GAMP 5 outlines a scalable approach to computer system validation (CSV), requiring documentation and control over system functions. V5 supports this by providing:
- Installation Qualification (IQ): Verified installation of V5 modules, infrastructure, and components
- Operational Qualification (OQ): Functional test protocols to confirm V5’s system behavior aligns with specifications
- User Acceptance Testing (UAT): Templates and support to execute customer-specific scenarios for final sign-off
- Audit Trail: Full traceability of user actions, system changes, and digital signatures
- Role-Based Security: Controlled access aligned to regulated user roles (QA, production, admin)
Our team provides a standard validation package and supports clients in performing risk assessments, UAT scripting, and maintaining ongoing compliance.
Validated Control Without Red Tape
Unlike legacy systems that require costly third-party CSV services, V5 comes with built-in validation protocols and tools that simplify compliance without sacrificing rigour:
- GAMP 5-aligned documentation for all core modules (MES, QMS, WMS)
- Support for periodic revalidation and system updates
- Digital signatures, audit logs, and version control for regulated changes
- Templates for UAT tied to functional requirements and process maps
- Compatibility with 21 CFR Part 11, EU Annex 11, ISO 13485, and PIC/S
Compliance is built in—not bolted on. V5 ensures traceable execution, secure records, and inspection-ready validation outcomes.
Request Validation Documentation
SG Systems Global provides full IQ/OQ protocols and UAT guidance for every validated V5 deployment. If your team requires a validation pack or GAMP 5 documentation support, contact us to request access.
Whether you’re planning initial CSV or preparing for regulatory inspection, V5 helps you meet the expectations of GAMP 5—efficiently, clearly, and with confidence.
Explore how V5 modules support GAMP 5-aligned validation:
