FDA & GxP Regulated Compliance Automation
Validator streamlines validation, ensures data integrity, and keeps every FDA/GxP regulated operation audit-ready—helping your team sustain compliance in a fast-changing regulatory world.
Consistent, Audit-Ready Compliance for FDA & GxP Regulated Environments
For organizations operating under FDA or global GxP oversight, compliance is a daily mandate—not just an annual hurdle. Whether you’re in manufacturing, quality assurance, R&D, or clinical development, staying on top of every regulatory requirement means managing constant documentation, validation, and change. The stakes are high: missed steps or poor records can lead to findings, operational disruption, or even reputational risk.
Validator ensures FDA and GxP regulated companies achieve dependable, traceable, and future-proof compliance. Designed by validation professionals who know how regulations, data integrity, and quality intersect, Validator automates the entire compliance lifecycle—making it easy to adapt to evolving standards, control documentation, and prepare with confidence for every inspection.
Purpose-Built for Regulated Operations
Validator is trusted by teams who cannot afford compliance lapses, lost data, or audit-day surprises:
- Comprehensive Validation Automation: From computer system validation to equipment qualification, Validator ensures every protocol, record, and control is automatically created, updated, and traceable—reducing gaps and preparation time.
- Data Integrity & Electronic Records: Validator meets FDA 21 CFR Part 11 and EU Annex 11 standards for electronic signatures, audit trails, and access management. You always know who did what, when, and why, across every system.
- Change Control and Risk Management: Automate change requests, impact assessments, and risk-based validation; maintain your validated state through upgrades, new processes, or scale-up.
- Integration and Accessibility:
Connect Validator to your LIMS, MES, ERP, and QMS. Ensure every location and team has up-to-date compliance documentation and data at their fingertips.
Technical & Regulatory Excellence
- GAMP 5, CSA-first, 21 CFR Part 11, and EU Annex 11 aligned—no add-ons needed
- Complete role-based security, dual-authentication e-signatures, and automated version control
- Built-in business continuity and disaster recovery best practices for electronic recordkeeping
Results That Stand Up to Scrutiny
- Audit-Ready, Always: Continuous documentation, version history, and audit trails ensure you pass inspections with less stress and greater confidence.
- Efficiency Gains: Teams save 40% or more on compliance workload, freeing resources for innovation and critical business needs.
- Global Scalability: Support for multi-site compliance, remote audits, and distributed quality teams.
- Every Implementation a Reference: “Ask any current client—every Validator project is 100% successful.”
Who Benefits?
Pharma, biotech, medical device, diagnostics, CDMO/CRO, and any life sciences organization bound by FDA, EMA, or global GxP requirements.
Tailored Automation For Every Validation
Validator is designed to tackle your biggest compliance pain points either one process at a time or across your entire validation lifecycle.
Explore each core solution to see how Validator can streamline your work and strengthen your audit confidence.
Computer System Validation (CSV)
Validator automates every phase of system validation, from protocol creation to risk management and compliance documentation. Records and traceability are built in and reliable, keeping your systems audit-ready at all times.
Process Validation (PV)
Experience more control and fewer surprises with automatic protocols, batch records, and trend data integration. All three stages of process validation—design, qualification, ongoing review—move faster and smarter with Validator.
Equipment Qualification (EQ)
Keep every asset documented and up to date. From installation through annual verification, Validator manages every protocol, document, and calibration so you’re always ready for inspection.
Cleaning Validation
Cleaning schedules, procedures, and proof are managed for you. Auditors get instant access to every record, while your team has more time for high-value work.
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
How does Validator help maintain compliance with FDA 21 CFR Part 11 and EU Annex 11?
Validator is designed to meet FDA and EU requirements for electronic records and signatures. It provides comprehensive audit trails, secure access controls, e-signatures, and automated record retention for seamless regulatory compliance.
Can Validator support multi-site and global GxP operations?
Yes. Validator is scalable for organizations with multiple sites, international facilities, and distributed teams—ensuring consistent validation, documentation, and compliance oversight everywhere you operate.
How does Validator handle frequent audits and inspection readiness?
Validator keeps all validation documents, approvals, and audit trails organized and instantly accessible. With real-time dashboards and search, your team is always prepared for scheduled or unannounced inspections.
What processes, equipment, and systems can Validator automate for FDA/GxP compliance?
Validator automates computer system validation (CSV), process validation (PV), equipment and cleaning qualification, change control, and integrates with LIMS, ERP, and QMS—covering all documentation required for regulatory submissions and ongoing audits.
Testimonials
Here are a few of our client and their testimonials
