Computer System Validation (CSV) Automation
Stay audit-ready, eliminate manual work, and validate with confidence without chasing signatures or spreadsheets.
Transform Your Computer System Validation
Reduce audit findings
Eliminate duplicate manual work
Automate traceability
Customize to your workflow and regulatory landscape
Focus On Science, Not Paperwork
Still using spreadsheets or paper to manage computer system validation? You’re not alone—but it’s risky, time-consuming, and holding you back.
Validator brings structure and automation to your Computer System Validation (CSV) process, whether you’re validating lab, manufacturing, or business systems. Built around GAMP 5 and FDA CSA principles, it adapts to your workflow, eliminates rework, and frees your team from chasing signatures. Implementation is fast, seamless, and led by real CSV experts who’ve done the work themselves.
All-in-One CSV Tool
- 21 CFR Part 11–compliant e-signatures for electronic approvals
- Automatic audit trail and data integrity features that meet global regulatory standards
- Impact assessment engine helps maintain validation during system upgrades
- Traceability matrix links requirements to tests and results for clear coverage
- Change control is built into the validation workflow—no disconnected systems
- GAMP 5-aligned lifecycle from User Requirements to Validation Summary Reports
- Risk-based testing reduces busywork and supports FDA's CSA guidance
- Comprehensive support for audit trails, e-signatures, and data integrity by default
How Validator Automates Your Computer System Validation
Validator follows the GAMP 5 V-Model approach, scaling validation effort based on system complexity and risk. Every stage, from planning to maintenance, is digitized and automated for compliance, traceability, and team clarity.
Planning and Requirements
Validator starts by creating a robust Validation Master Plan that fits your quality system. This captures functional and non-functional user requirements, and uses GAMP 5 risk assessment tools to determine your validation strategy.
Design and Configuration
Validator records all configuration details and decisions. It auto-generates System Configuration Specifications and ensures requirements are properly translated into design. Supplier audits and documentation are kept centralized and accessible.
Testing and Verification
Validator automatically tracks records, test execution, and deviations so it can manage all testing phases—IQ (installation qualification), OQ (operational), and PQ (performance). Each protocol and result is mapped back to requirements for complete traceability.
Reporting and Maintenance
Validator finalizes your project with clear Validation Summary Reports. When changes or upgrades occur, built-in change control and periodic review tools ensure you never fall out of compliance.
Global Standards Are Always Covered
Validator’s CSV solution addresses all major guidelines
FDA 21 CFR Part 11:
- Electronic records with robust controls and audit trails
- Dual-component e-signatures
- System access controls
- Full record retention and retrieval
EU Annex 11:
- Risk-based validation
- Vendor/supplier assessment and management
- Data integrity and audit trails
- Disaster recovery, continuity planning
GAMP 5:
- Scalable validation based on risk
- Supplier involvement as needed
- Lifecycle maintenance, integrated change control
- Integration with your overall quality management system
Backed By Numbers
40%
Time saved on validation projects
300+
Successful client implementations
100%
Audit-ready documentation success
20k
Active users in regulated industries
Industries We Support
Pharmaceuticals, biotechnology, medical devices, and all FDA/GxP regulated organizations rely on Validator for CSV that is practical, scalable, and always aligned to current standards.
Compliance That’s Proactive, Integrated, And Ready For What’s Next
Not all platforms are created equal. Validator is shaped by experience—built and implemented by people who have worked inside life sciences teams, led audits, and solved real regulatory problems.
Constant
Compliance
Real-time dashboards create a living audit trail, so your team works from current data and your compliance stays inspection-ready.
Integrated With Your Systems
Every connection is fully configurable to your LIMS, ERP, MES, HR, finance, and risk systems with no custom code, so you can access and personalize without calling IT.
Fast ROI with Proven Efficiency
Achieve over 40% efficiency gains and 100% implementation success. Fast ROI with Validator fully configured and running smoothly within 3 months.
Always Up-to-date
As regulatory standards evolve, so does Validator, to ensure your validation system follows CSA and globally aligned practices for international compliance.
Frequently Asked Questions
What is Computer System Validation (CSV) and why is it important?
CSV is a documented process used to ensure that computerized systems—such as LIMS, MES, and ERP—perform as intended and meet regulatory requirements. Validating these systems is essential to protect data integrity, ensure product quality, and pass audits from agencies like the FDA and EMA.
How does Validator automate computer system validation?
Validator automates every stage of the CSV process—from planning and risk assessment to protocol generation, execution, approvals, and reporting. It eliminates manual data entry, automates traceability, and keeps documentation audit-ready at all times.
Can Validator adapt to our company’s unique SOPs and workflows?
Absolutely. Validator is fully configurable to your procedures, risk models, and approval chains—no custom development needed.
How does Validator handle changes, upgrades, or new systems?
Validator includes built-in change control and impact assessment workflows, so every modification or upgrade is tracked, assessed for risk, and validated to maintain compliance over the system’s lifecycle.
Can Validator integrate with our other business and quality systems?
Yes. Validator is designed for seamless integration with LIMS, MES, ERP, and other enterprise platforms, ensuring data flows smoothly and validation records stay complete.
How quickly can we go live with Validator for CSV?
Many organizations are fully implemented in as little as 2–4 months. Our team handles configuration and onboarding to get your team compliant and confident quickly.
Who supports us during and after implementation?
Validator is implemented and supported by the experts who built it—not third-party consultants—so you get consistent, expert guidance from day one through every future regulatory change.
Testimonials
Here are a few of our client and their testimonials
