Ensure Your Monitoring System Is Audit-Ready from Day One
Regulatory compliance starts with a validated system. From software to sensors, we provide full EMS validation services that help you meet FDA and industry requirements with confidence.
Need to validate a new system?
Software Validation & FDA CFR Part 11 Compliance
Our validation services include comprehensive software validation, ensuring that your systems comply with FDA CFR Part 11 regulations. We meticulously verify that electronic records and signatures are secure, reliable, and compliant, providing you with confidence in your system’s regulatory adherence.
Installation Qualification (IQ) & Operational Qualification (OQ) Protocols
As a foundation of our validation process, our Installation Qualification (IQ) and Operational Qualification (OQ) protocols guarantee that your systems are installed and operate according to manufacturer specifications and regulatory standards.
Ensuring Compliance and Reliability
Our validation process is designed to provide critical data integrity and operational efficiency, ensuring that your monitoring systems are not only compliant with industry standards but also accurate and reliable.
Trust Rees to deliver comprehensive validation services that support your commitment to excellence.
Frequently Asked Questions
Calibration ensures that each sensor is accurately measuring the parameter it’s designed to monitor, such as temperature or humidity. Validation, on the other hand, is a broader process that confirms the entire monitoring system, including software, hardware, and processes, performs as intended and meets regulatory requirements. Calibration is often one step within a larger validation protocol.
Validation is not a one-time event. While initial validation occurs after system installation, revalidation may be necessary if there are significant changes to the system, such as software updates, hardware replacements, or relocation of equipment. Regular reviews and requalification activities help maintain compliance over time.
Yes, we support validation for SaaS and hybrid systems. Our validation protocols cover cloud-based monitoring environments, server nodes, and local physical sensor installations to ensure full system compliance and integrity, regardless of architecture.
You’ll receive comprehensive documentation, including executed IQ/OQ protocols, calibration certificates, software validation reports, and a validation summary report. These materials are essential for audits and regulatory inspections, and they provide traceable proof that your system is compliant and functioning correctly.
The duration depends on the complexity of your system, but most validations can be completed within a few days. We’ll work with you to schedule validation activities around your operational needs and minimize downtime.