Cleaning Validation
Standardize your cleaning procedures, automate your schedules, and centralize every record from sampling plans to test results to approvals.
Cleaner Compliance Every Time
Always inspection-ready with built-in audit trails and end-to-end traceability
Automate scheduling, approvals, and documentation across sites, equipment, and cleaning agents
Full integration into your ERP, LIMS, and LMS
Real-time monitoring and statistical analysis of cleaning test data
Does Your Current System Automate Everything From First Swab Records To Final Signatures?
A missed swab test, an outdated SOP and suddenly your team is scrambling ahead of an inspection. Cleaning validation is one of the highest-risk areas in audits, and when documentation is fragmented across systems and every change triggers revalidation, it quickly becomes the most time-consuming validation.
Validator brings standardization, speed, and control to every step of the cleaning validation process.
Cleaning Validation That Practically Runs Itself
- Reduced validation cycle times with automated workflows and alerts
- Risk-based revalidation recommendations using built-in FMEA and risk models
- Change management for materials, equipment, rooms, and cleaning methods
- Automated MACO calculations for cross-product and cross-equipment scenarios
- Site-based room and equipment management with centralized oversight
- Test profile and CQA tracking with configurable sampling plans
- Digital cleaning logs, training records, and study management (e.g., worst-case, clean/dirty hold time)
- AI-driven data mining for faster insights and audit prep
- Comprehensive, flexible reporting that is always up to date, always audit-ready
How Validator Automates Your Cleaning 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 for 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.
Regulatory Ready By Design
- 21 CFR Part 11: Full audit trail, e-signature, access control, record retention, and retrieval
- EU Annex 11: Risk-based, data integrity, vendor assessment, disaster recovery
- GAMP 5 and risk-based approaches: Lifecycle-based, supplier involvement, scalable protocols, and integration with QMS
- 21 CFR Part 11 & EU Annex 11: Digital records, e-signatures, audit trails, trending, and risk-based compliance
- Continuous improvement and CAPA built into each stage
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
Pharma, biotech, med device, and all regulated labs or manufacturing teams that need transparent, reliable, and efficient equipment qualification.
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 equipment qualification, and why is it critical for compliance?
Equipment qualification verifies that lab and manufacturing equipment operate correctly and consistently, meeting all regulatory requirements. It’s essential for ensuring product quality, data integrity, and audit readiness.
How does Validator automate the equipment qualification process?
Validator streamlines each step—installation (IQ), operational (OQ), and performance qualification (PQ)—by generating, routing, and securely storing all required protocols and records with built-in approvals and alerts.
Can Validator handle changes or requalification of equipment over time?
Yes. Validator’s built-in change control workflow manages impact assessments and requalification, ensuring all modifications are tracked and validated throughout the equipment lifecycle.
Is Validator compliant with global regulatory requirements for equipment qualification?
Absolutely. Validator supports FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards, providing complete audit trails, electronic signatures, and documentation integrity.
How does Validator ensure nothing is missed before an inspection?
Validator provides real-time dashboards, alerts for overdue tasks, and instant access to all qualification and calibration records—so your team is always inspection-ready, with no surprises.
Testimonials
Here are a few of our client and their testimonials
