Streamline validation with our computer software assurance solution
Go paperless with our effective computer software assurance solution. Global collaboration has never been easier. Our digitized process includes failsafe mechanisms and helps you cut costs across the board.
The Future of Software Validation
Streamline Validation Process
Save time by choosing our completely digital solution. Complete the project in record time without cutting corners.
Reduce Execution Errors
Our guided test case execution allows you to stay on track. It’s almost impossible for execution errors to slip through the cracks, saving you time and money.
Eliminate GDP Errors
Avoid any potential GDP errors with our effective solution. Compliance with Part 11, Annex 11 and Chinese NMPA has never been easier.
Global Collaboration
Collaborate on a global scale with an entirely paperless system. All team members can contribute without affecting productivity.
Validation Tie & Cost Reduction
Cut costs across the board by saving time and resources. Our digitized solution keeps costs low by allowing you to save files locally.
Paperless
Reduce reliance on paper validation by implementing our solution. Modernize your existing processes and keep your team on track.
How It Works
Our computer software assurance is effective and easy to understand. We’ve made validation easier than ever to keep your team moving without risking compliance errors.
DRAFT
Get the project started with the help of guided test case execution.
REVIEW
Allow colleagues around the world to review your results and leave feedback.
EXECUTE
APPROVE
Send your test case off for approval with ease.
Get Started
Change the way you complete validation projects in a matter of minutes. Give us a call today to learn more about how we can help.
A Solution That Works For You
Integrated Deviation Handling Workflow
Find clear corrective action before implementation.
21 CFR Part 11, Annex 11, Chinese NMPA Compliance
Stay compliant with various regulations across your organisation.
Book a Demo
Try it for yourself and see how effective it can be. Contact us today for a free demo of our computer software assurance solution.
Commonly Asked Questions
Computer Software Assurance (CSA) is a testing process. This form of testing is limited to functions directly impacting patient safety and product quality. CSA is typically used for high-risk activities only. Each element of the software is tested thoroughly.
Software validation ensures that the software meets the specified and pre-defined business requirements. This process evaluates the software product and ensures that it meets the demands of end-users or customers.
21 CFR Part 11 is a Code of Federal Regulation that is relevant across various industries. 21 CFR Part 11 details the criteria that applies to electronic signatures and records that are considered to be trustworthy.