Equipment Qualification Automation
Run the entire Equipment Qualification process in one place so equipment is always documented, linked, and audit-ready.
Assurance from Installation to Inspection Every Time
Seamless IQ/OQ/PQ automation for setup, operation, and performance
Always inspection-ready with built-in audit trails and end-to-end traceability
Change-ready compliance for every upgrade and modification
No missed maintenance thanks to real-time monitoring and automated reminders
Faster, leaner validation that allows you to scale without more admin
The First Step To Passing Every Audit
Equipment qualification is more than a checkbox—it’s the foundation for regulatory trust and consistent product quality.
If you’re relying on the standard manual protocols, Excel trackers, lost vendor docs, and manual re-validation every time there is an upgrade, equipment qualification is difficult — hello, last-minute audit scrambles and teams under constant pressure.
Validator changes the game, automating and organizing the entire lifecycle of equipment qualification. Instead of piecing together paperwork, your team gains visibility, control, and peace of mind from installation to decommissioning.
Validator Replaces The Chaos With One Automated Workflow
- Every step accounted for – Automatic logging, timing, and measurement of every test so nothing slips through the cracks.
- Instant issue notification – Deviations and CAPAs are flagged, tracked, and resolved without slowing progress.
- Complete traceability – Link URS to every IQ/OQ/PQ test and result, mapped to equipment configuration and SOPs.
- Compliance built-in – Designed for GAMP 5, risk-based approaches, and 21 CFR Part 11–compliant e-signatures.
- Audit-ready at all times – Full audit trails that prove data integrity and regulatory credibility on demand.
- Change without chaos – Integrated change control and impact assessment keep assets validated through upgrades.
- One streamlined platform – Replace scattered files with one place to route, track, and log every validation task, freeing your team to focus on science and improvement instead of chasing signatures.
From Day One To Audits
Validator structures equipment qualification for maximum compliance and operational ease in 4 stages.
Planning & Risk Assessment
Validator starts by developing a robust qualification master plan, mapping equipment to user and business needs (URS), and assessing risk to scale testing. Everything is calibrated to your quality system and regulatory landscape.
Design & Supplier Management
Validator captures vendor documentation, manages supplier audits, and links to equipment lifecycle files. Supplies info, protocols, and performance criteria are all centralized.
Testing & Lifecycle Verification
Validator automates the generation and execution of IQ (installation), OQ (operational), PQ (performance), calibration, and requalification protocols so that every test step, deviation, and action is tracked.
Change Control & Maintenance
Validator generates impact assessments to support post-validation changes, ensuring no upgrades threaten compliance. Now, ongoing reviews, annual requalification, and documentation updates are easy and painless.
Stay Regulated During Equipment Qualification
- 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 operates 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
