Driving A Culture of Quality and Compliance

 

Enterprise Quality Management Systems (eQMS) are a mature technology foundation.  The architecture of these systems vary from vendor to vendor.  The validation of these systems is a constant.  Most software vendors provide a stack of validation documentation for these systems that require some knowledge of the basic operation of the system while others will validate the system for you.

In the "General Principles of Software Validation; Final Guidance for Industry and FDA Staff", issued on January 11, 2002, the FDA states "...If the vendor can provide information about their system requirements, software requirements, validation process, and the results of their validation, the medical device manufacturer can use that information as a beginning point for their required validation documentation..."

THE BEGINNING OF VALIDATION

The Validation Accelerator is the beginning of the validation for your Quality Management System.  The Validation Accelerator provides all of the system requirements, validation test documentation coupled with an automated, ready-to-use Enterprise Validation Management system to drive your lean validation process.  

WANT TO ACCELERATE YOUR NEXT QMS VALIDATION PROJECT?

Contact us today for a private, no-obligation demonstration of our QMS validation accelerators and let us show you how we can quickly and easily validate your cloud or on-premise solutions

CloudMaster 365™ QMS Accelerators

 

ValidationMaster™ Quality & Risk Management Portal

 

QUMAS Quality and Compliance Management ®

 

EtQ® Quality Management & EHS Solution

 

MasterControl® Quality Management System

 

AssurX® Enterprise Quality Management System

 

HP Quality Center® 

 

More Information

Accelerate Your ROI

One of the key benefits of CloudMaster 365™ is the excellent return on investment of the solution.  CloudMaster 365™ is delivered with a full, comprehensive Enterprise Validation Lifecycle Management and Quality system known as ValidationMaster™.  Beyond the initial validation exercise, CloudMaster 365™ pays dividends well beyond the initial validation exercise.  Many companies have seen a 100% return on investment with the first project.

Learn More

We invite you to access our Download Center and read more about our Validation Accelerators.  Our download center includes case studies, marketing collaterals and data sheets, white papers and much more.  Read our blog branded as The Validation Post for more detailed indepth strategies, best practices and thought leadership on lean validation strategies, Validation Accelerators and the latest innovations for validation project management.

Innovation In Action

Life sciences companies across the globe are seeing the benefits of our CloudMaster 365™ Validation Accelerators.  Instead of getting a stack of documents from a vendor, CloudMaster 365 provides you with the system, the documentation, the testing, and the processes to help deliver validation.  Our clients have added their own due diligence to ensure compliance with current regulatory guidelines. 

Mastering Regulatory Compliance

CloudMaster 365 is compliant with current global regulatory guidelines.  The ValidationMaster Enterprise Validation Lifecycle Management system includes compliance with 21 CFR Part 11, change control, regulatory content management, incident management, CAPA, nonconformances, training and other regulatory processes.  The system is designed to work together in a cohesive manner to deliver maximum value for lean validation processes.