TURNKEY IV&V PROFESSIONAL SERVICES
Features & Benefits
Our validation project managers are masters at delivering projects on time and within budget. We ensure that your project is managed in accordance with best practices and that all resources are effectively utilized.
As part of our validation services, we conduct a comprehensive risk assessment and a 21 CFR Part 11 assessment to ensure that your validated system is in compliance. For European clients, we conduct an EU Annex 11 assessment for compliance with the EU standard for validation.
Validation test script development and execution is central to all validation projects. Our experienced validation professionals can assist with the development of test scripts in accordance with global regulations using our advanced automated tools.
CloudMaster 365 delivers the ValidationMaster™ system coupled with a complete set of “out-of-the box” requirements, validation templates and IQ/OQ/PQ test scripts pre-loaded and ready to execute within the ValidationMaster™ system. The Validation Accelerators are designed to save both time and money and avoid duplication of effort
For each ValidationPro℠ engagement, we offer a customized validation workshop to help establish common ground and plan each project to ensure success.
Standard Operating Procedures (SOPs) are essential for validation good governance. Without SOPs, one cannot successfully conduct validation activities. Through ValidationPro℠, we provide expert guidance in developing SOPs to provide governance for your validation processes.
Through ValidationPro℠, we prepare all validation document deliverables to support each validation project. Our team of experienced validation engineers are experts at writing validation documentation and will prepare each document in accordance with your unique SOPs to ensure compliance.
ValidationPro℠ is a unique full-service, turnkey IV&V professional services offering that delivers experience, independence, and automated tools to accelerate validation projects and ensure compliance. We complete ALL validation deliverables on your behalf while freeing up your internal team for other mission-critical tasks.