Validator: Digital Validation Automation For Real-World Life Sciences
The New Standard for Compliance
Regulatory demands in life sciences never rest, and outdated tools keep teams trapped in a cycle of manual work, audit stress, and constant fire drills. Validator is the breakthrough: a comprehensive, fully automated compliance platform engineered by seasoned validation professionals—built for how you actually work and designed to end the inefficiency of paper-based and fragmented digital processes.
Unlike basic digitization or document management tools, Validator seamlessly integrates with your existing business systems and automates validation workflows and content management—ensuring data integrity and audit readiness at every step. That means fewer manual tasks, minimized risk of human error, and up to 40% efficiency improvements for your team.
Easy to implement and backed by real experts from start to finish, Validator empowers you to achieve and sustain compliance, pass audits with confidence, and focus resources where they matter most.
Why Leading Validation Teams Choose Validator
- End-to-End Automation: Automate every step of validation—no more piecemeal templates or manual data entry.
- Direct Partnership: Validator is delivered and supported exclusively by Compliance Associates. No partner handoffs, just results.
- Always Audit-Ready: Complete, real-time traceability, automated documentation, and dashboards keep you in control, not in catch-up mode.
- CSA-First, Future-Proof: Validator is designed around Computer Software Assurance (CSA), risk-based validation, and current FDA/EMA expectations.
- Transparent, Fair Licensing:
Choose SaaS (cloud) or vMFL (Validator Multi-Flex License)—every feature, every team, always accessible with predictable pricing.
How Validator Works For You
Discovery & Process Mapping
It starts with a collaborative mapping session—understanding your workflows, systems, and regulatory needs. No generic templates, just practical insight.
Direct Configuration & Integration
Validator automates your validation process, integrating seamlessly with business systems to keep you compliant without requiring significant time or costly manual effort.
Automated Validation Execution
- Auto-generates validation plans, protocols (IQ/OQ/PQ), and traceability matrices
- Flags missing, incomplete, or inconsistent records as you go
- Provides built-in risk assessments at every user, functional, and design point
- Sends real-time alerts for overdue tasks, deviations, or missing approvals
- Supports electronic test execution with multimedia capture—making proof effortless
Always in Control, Always Audit-Ready
A living audit trail with portfolio dashboards, vendor audit tracking, version control, time stamps, and secure signatures.
“Validator is invaluable… With it, we have a far more efficient process overall.”
– Eric David, Biogen
Rapid User Adoption & Ongoing Support
Intuitive interface, hands-on onboarding, and continuous quarterly reviews. Validator “learns” your organization—getting smarter and more efficient with every use.
What Validator Automates
Computer System Validation (CSV)
Take the guesswork and manual pain out of computer system validation. Validator automates every step—planning, protocol generation, execution, and traceability—delivering audit-ready documentation in less time and with less risk.
- Plan, execute, and document all validation activities (cloud or on-prem)
- Auto-generates VP, VRA, URS/FRS/DRS, protocols, traceability, audit summaries
- Built-in compliance with 21 CFR Part 11 and global GxP requirements
Process Validation (PV)
Manage all stages of process validation seamlessly. Validator automates design, qualification, and ongoing verification, so trending, deviations, and batch documentation are tracked in real time and always inspection-ready.
- Manage all three stages of process validation (design, qualification, ongoing)
- CPP and CQA tracking, trending, and data integration (ERP/LIMS)
- Real-time batch reporting, FMEA tools, automated annual review docs
Equipment Qualification (EQ)
Keep your equipment compliant and audit-ready without drowning in paperwork. Validator automates qualification from install through requalification, giving you full lifecycle control, instant alerts for deviations, and organized records at your fingertips.
- Complete lifecycle management from install to decommissioning
- Track IQ/OQ/PQ, configuration, change control, vendor documentation, and calibration
- Real-time alerts for deviations or failed qualifications
Network Qualification & Infrastructure
Ensure your IT infrastructure meets compliance demands—without slowing you down. Validator qualifies server and network environments, automates risk and change documentation, and supports hybrid and cloud systems for smooth, secure digital operations.
- Validated server/network/infrastructure qualification for compliance
- Risk assessments, change documentation, reliable hybrid/cloud support
Integrated System/Data Support
Bring all your validation, data management, and documentation systems together. Validator streamlines archiving, interfaces with ERP and LIMS, and enables effortless migration to a paperless, future-ready environment—keeping your data integrated and accessible, always.
- Archiving, legacy system retirement, seamless digital record conversion
- Onsite and remote testing, independent verification, paperless validation environments
Flexible Licensing For Every Team
Fair pricing with no volume discounts—everyone gets full feature access at the same low rate.
SaaS
- Cloud-based
- No minimum licenses
- Named-user pricing
- Monthly billing
- Constant state of validation
vMFL (Validator Multi-Flex License)
- On-prem or hybrid
- Concurrent-user model
- Ideal for multi-site teams
- Annual support and optional execution bundles
Built by Practitioners, Not Just Developers
Validator was shaped by the people who live compliance every day.
We know the urgency of audit prep, the challenge of running lean teams, and the headaches of complicated tools. Validator is built to support your work, never slow you down—and our team stays with you from the first call through every milestone.
Ready to Start?
Request a demo to see Validator in action with your data and workflows.
Visit the Validator Website for more details, technical specs, and client stories.
Let’s make your validation process truly digital, always audit-ready, and ready for what’s next.
Frequently Asked Questions
What makes Validator different from other validation tools?
Validator is built by professionals who work in validation daily. It automates the entire process—not just the documents—making traceability, test execution, and audit readiness fully integrated and hands-off.
Can Validator handle all three stages of Process Validation?
Yes. Validator supports Stage 1 (Process Design), Stage 2 (Process Qualification), and Stage 3 (Continued Process Verification) with automated documentation, trending analysis, and batch data integration.
Is Validator compliant with CSA and regulatory requirements?
Absolutely. Validator is designed around CSA (Computer Software Assurance) principles and supports risk-based validation in line with FDA, EMA, and other regulatory frameworks.
What types of businesses can use Validator?
Validator is scalable for both small and large organizations. It supports cloud-based SaaS for small teams and enterprise-grade deployments through its vMFL license for larger, multi-site operations.
How does Validator support audit readiness?
Validator creates a living audit trail with complete traceability, timestamped actions, and multimedia test evidence. Its dashboard, vendor audit tracking, and notification system ensure you’re always prepared.
Testimonials
We're proud of having worked with over 300 clients in the past 25 years.
Here are a few of our client and their testimonials
