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What is it and who needs it?

Software validation is a process that documents and confirms a computer system or software is working correctly and being used as intended. The U.S. Food and Drug Administration (FDA) requires software validation from the organizations they regulate, so we created these offerings with our FDA customers in mind. However, software validation isn’t an FDA-specific process, and implementing it can be useful for any organization that wants to prove that critical software is operating as intended.

Why Qualtrax?

We make it easy for you. Here’s an example: You’re a med device manufacturer that’s regulated by the FDA. You want to implement an eQMS like Qualtrax to save your team time and assure your continued accreditation and compliance. You hit a roadblock, however, when you remember that the FDA requires you to validate any software that could impact product quality, safety, or effectiveness. Instead of leaving you to fend for yourself and figure out how your organization is going to validate the software, we do the heavy lifting for you.

Which platform best suits my needs, Silver or Gold?

If you’re already familiar with Qualtrax, then you know that the Validation Platforms build on a strong foundation of technical controls necessary for 21 CFR Part 11 compliance: automated change control, electronic signature via Password Verification, Comprehensive Audit Trails, Customer/Regulatory Audit Management. It’s all easy, configurable, and reportable. The main differentiator between the two being that the Silver platform is better for those who prefer or are required to create their own operational qualification reporting. Gold is better for those who prefer to save time and resources by having someone else do it.