Turnkey IV&V Professional Services

 

We understand the business imperative to work smarter, not harder. Through ValidationPro℠, we deliver ready-to-work IV&V teams with the requisite practical hands-on knowledge and advanced test automation tools to optimize any type of validation project. Our team consists of a validation project manager, validation systems engineer and a validation test engineer.

The ValidationPro℠ team works closely with your implementation team to ensure a cohesive approach to your project. From beginning to end, we manage your validation project to enable your internal resources to focus on other initiatives that impact your bottom line. Our ValidationPro℠ specialists come from the ranks of leading life sciences organizations. Each expert brings over a decade or more of enterprise validation experience to your project.

ValidationPro℠ professional services are delivered with a straightforward mission – to deliver a fully validated system leveraging a ready-to-work validation team. Our experts will coach your team on validation activities that establish and sustain validated environments while ensuring compliance.

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CONTACT US TODAY ABOUT YOUR NEXT VALIDATION PROJECT!

We specialize in the validation of enterprise technologies such as Microsoft Dynamics 365, Microsoft Azure, SAP, Enterprise Content Management, Enterprise Quality Management and other such systems. Contact us today if you have a project in mind. We can help!

Service Features & Benefits

Validation Project Management

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.

ValidationPro Custom Workshop

For each ValidationPro℠ engagement, we offer a customized validation workshop to help establish common ground and plan each project to ensure success.

System Risk & 21 CFR Part 11 Assessment

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.

 

SOP Development Assistance

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.

Test Script Development & Execution

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.

 

Document Preparation & Management

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.

CloudMaster 365 Validation Accelerator

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

 

Turnkey Validation Services

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.