Computer System Validation (CSV)
Quick Navigation: Overview • Challenges • Typical Engagement • Our Approach • Client Profile
Service Overview
Computer system validation in life sciences requires balancing regulatory compliance with operational efficiency and innovation speed. We provide systematic validation approaches that focus resources on actual operational risks rather than generic compliance checklists, creating audit-defensible documentation while minimizing validation overhead.
Common Challenges
Organizations struggle with validation projects that consume enormous resources without addressing real operational risks, audit findings that expose gaps in system integration documentation, and testing protocols that focus on theoretical scenarios rather than actual usage patterns. Specific situations requiring strategic validation approaches include:
Legacy system modernization where existing validated systems must be replaced or integrated with new technologies while maintaining compliance status and operational continuity. Enterprise system implementations involving ERP, LIMS, QMS, or clinical systems that require validation across multiple sites and business processes while avoiding disruption to revenue-generating activities.
Data integrity initiatives that demand systematic documentation of how data flows between systems, who can modify it, and how changes are tracked and approved across the entire data lifecycle. AI and machine learning system validation requiring new approaches to demonstrate system reliability and decision-making transparency within traditional regulatory frameworks.
Cloud migration projects where validated on-premise systems move to cloud infrastructure, requiring validation of new technical architectures while maintaining existing business process controls. Merger and acquisition integrations where different validation approaches and documentation standards must be harmonized across organizations.
Digital validation platform implementations using tools like Valkit to automate validation processes while ensuring the validation methodology itself meets regulatory standards and audit requirements.
Most validation failures occur because teams validate individual systems without understanding how data flows between them, leading to compliant systems that can’t support integrated business operations.
Recent Engagements
- Pharmaceutical manufacturer implementing cloud-based QMS across five manufacturing sites while maintaining GMP compliance and avoiding production disruption
- Biotech company validating AI-assisted batch record review system for regulatory submission readiness
- Medical device manufacturer harmonizing validation approaches across acquired facilities with different regulatory histories and system maturity levels
Typical Engagement
Duration: 3-6 months for major system validation, ongoing for validation program optimization
Deliverables: Validation strategy, system risk assessments, workflow documentation, testing protocols, validation reports, audit-ready documentation packages
Client involvement: Executive sponsorship required, cross-functional validation teams, subject matter expert interviews, user acceptance testing coordination
Engagement model: Project-based for specific validations, retainer-based for ongoing validation program management
Our Validation Approach
1. Workflow Documentation First We map how work actually gets done before designing validation protocols. This prevents the common problem of validating theoretical processes that don’t match operational reality.
2. Data Flow Analysis We document how data moves between systems, identifying critical integration points and potential single points of failure that require focused validation attention.
3. Risk-Based Testing We focus validation effort on system functions and data flows that pose the highest risk to patient safety, product quality, and regulatory compliance rather than generic testing templates.
4. Audit-Defensible Methodology We create validation approaches that are systematic enough to withstand regulatory scrutiny while being practical enough to execute within realistic timelines and budgets.
5. Integration Validation We test not just individual system functions but how systems work together to support end-to-end business processes, preventing the common problem of compliant systems that can’t support integrated operations.
Integration Points
CSV validation connects with all other compliance functions - system implementations require validation planning from project inception, GxP compliance depends on validated systems that actually work together, and ISO certification audits increasingly focus on system integration and data flow controls.
Change management programs support validation success by ensuring user adoption and process compliance beyond technical validation completion. Risk management frameworks guide validation scope and testing priorities, ensuring resources focus on actual operational vulnerabilities.
Client Profile
Organizations implementing new systems or upgrading legacy infrastructure where validation requirements could derail project timelines or budgets. Particularly valuable for companies facing regulatory inspections, managing complex system integrations, or needing to demonstrate data integrity across multiple platforms and business processes.
Ready to discuss your validation challenges? Contact us to explore how systematic validation planning can prevent expensive rework and audit findings.
Connect with Kevin Shea on LinkedIn for ongoing insights on life sciences technology and compliance.