System Validation Execution
Complete IQ/OQ/PQ validation for your critical systems with inspection-ready documentation in 6-12 weeks.
$40K-$120K
Per system
6-12 weeks
Timeline
10+
Deliverables
Complete System Validation Execution
Our system validation service provides end-to-end IQ/OQ/PQ execution for your critical GxP systems. We deliver complete, inspection-ready documentation that demonstrates compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. Whether you're implementing a new system, remediating validation gaps, or replacing legacy platforms, we ensure your systems are properly validated and audit-ready.
Complete Validation Documentation
Everything you need for inspection-ready system validation
Who This Is For
New System Implementations
Companies implementing new GxP systems who need validation from day one. We integrate validation activities into your implementation timeline to avoid delays and ensure compliance before go-live.
Validation Remediation
Organizations with systems already in production but never properly validated. We create retrospective validation documentation that demonstrates the system is fit for intended use and compliant.
Legacy System Replacement
Teams replacing legacy systems with modern platforms (cloud, SaaS, AI/ML). We validate new systems while ensuring proper data migration and continuity of validated state.
Validation Backlog Projects
Companies with multiple systems requiring validation, preparing for audits or inspections, or working through CAPA findings related to computer system validation.
Systems We Commonly Validate
Expertise across the full spectrum of GxP computerized systems
Veeva Vault Systems
QualityDocs, QMS, RIM, CTMS, and other Veeva Vault applications. Combined vendor-side and client-side expertise.
Discuss your systemLaboratory Systems
LIMS, ELN, and laboratory data management systems. Experience with LabWare, STARLIMS, Benchling, and Dotmatics.
Discuss your systemDocument Management
Document control, quality documentation, and regulatory document management systems.
Discuss your systemManufacturing Systems
MES, batch management, equipment automation, and manufacturing data systems.
Discuss your systemClinical Trial Systems
CTMS, EDC, eTMF, and other clinical systems. Experience with Veeva, Medidata, and Oracle platforms.
Discuss your systemCustom Applications
Bespoke applications, custom integrations, and internally-developed GxP systems requiring validation.
Discuss your systemOur Validation Process
1. Requirements & Planning
We begin by documenting User Requirements and developing a comprehensive Validation Plan. Our risk-based approach identifies critical functions and establishes appropriate testing levels per GAMP 5 guidelines.
2. Specification & Design
We document Functional and Design Specifications that detail how the system meets requirements. Our traceability matrix ensures every requirement maps to appropriate test cases.
3. Qualification Execution
We execute IQ, OQ, and PQ protocols with thorough documentation of test results. Our practical approach focuses on demonstrating the system works correctly for your business processes.
4. Summary & Approval
We deliver a Validation Summary Report documenting all activities, results, and deviations. The package includes procedures for ongoing periodic review to maintain validated state.
Why Choose IntuitionLabs for System Validation
Practical, Risk-Based
We follow GAMP 5 Second Edition risk-based principles. Our validation is thorough but practical - focused on what matters for your business and regulatory compliance.
Modern Systems Expertise
Deep experience with cloud, SaaS, and AI/ML systems. We understand how to validate modern platforms that traditional validation approaches weren't designed for.
Inspection-Ready Documentation
Our documentation is designed to withstand FDA inspection. Clear, complete, and traceable - we've supported clients through successful audits and inspections.
Combined Client + Vendor Perspective
Our team includes experts with 23 years at Pfizer (client-side validation for 65 manufacturing sites) and 13 years at Veeva Systems (vendor-side system expertise). This unique combination means we understand both what regulators expect and how modern systems actually work.
Learn more about GAMP 5 software categories and our approach to 21 CFR Part 11 compliance.
Investment & Timeline
Typical Investment: $40,000 - $120,000
Pricing depends on system complexity, number of modules, integration points, and validation scope. Factors include:
- System complexity and GAMP category
- Number of functional modules to validate
- Integration points with other systems
- Data migration requirements
- Retrospective vs. prospective validation
- Urgency and timeline constraints
Typical Timeline: 6-12 Weeks
Timeline varies based on system readiness and team availability:
- Weeks 1-2: Requirements and planning
- Weeks 3-4: Specifications and protocol development
- Weeks 5-8: IQ/OQ/PQ execution
- Weeks 9-10: Issue resolution and retesting
- Weeks 11-12: Summary report and approval
Expedited timelines available for urgent audit preparation.
Ready to Validate Your System?
Contact IntuitionLabs to discuss your system validation needs. We'll provide a detailed proposal with timeline and investment based on your specific requirements.
Discuss Your System