Validation Offerings
As FDA regulated industries move to paperless systems, a greater reliance has been placed on off-the-shelf products like CATSWeb. AssurX fully understands your requirements and concerns in meeting the stringent regulatory demands for software validation. A critical part of our product offering is providing you with superior validation support.
Installation Qualification (IQ) & Operational Qualification (OQ)
One of the first steps in software validation is performing Installation and Operational Qualifications (IQ/OQ). AssurX has developed a template IQ/OQ validation document. Each validation guides you through a step-by-step procedure including the description of test and expected results. With each CATSWeb version upgrade AssurX develops a revised IQ/OQ validation document reducing transition times.
Validation Services Available
The CATSWeb qualification documents are designed to be used and modified for do-it-yourself validations. If you prefer, validation services are available to perform any of the tasks you would rather outsource. This includes customizing the template IQ/OQ documents, developing a Process Qualification document customized to your CATSWeb usage and even performing the validation for you.
The Lowest Cost of Validation
How can we say that CATSWeb provides the lowest cost of validation? When CATSWeb was being developed - we acknowledged the fact that software validation is a significant cost driver for FDA regulated companies. Therefore CATSWeb was designed from the ground up to give you the absolute lowest cost of validation of any product on the market today.
The true Zero-ClientTM design means there is no code on any computer other than the server. This means you only have to validate the server as there is no requirement to validate the client computers. This also means that you have the flexibility to do the validation offsite which is very desirable when 3rd party validation services are utilized.
Zero-client means:
- Zero compatibility issues
- Lowest total cost of ownership
- Lowest risk
- Fastest performance
- Better security
We went through great lengths to ensure that our zero-client solution fully complies with the 21 CFR Part 11 FDA regulation. Take our challenge and ask this question of the other solutions you are considering, "is it 100% compliant and 100% browser based"? We have not found another solution on the market that can make this claim. So when you benchmark CATSWeb against other solutions consider the cost savings that goes along with our zero-client architecture.
