authentrics
Quality Assurance
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Authentrics has a long history of developing software under strict QA guidelines, including compliance with FDA CFR Part 11.

Validation

Our QA experts are available to take your systems through a process of formal validation, ensuring your customers a positive experience. From creating Validation Plans through executing them, we can lift the QA burden from your organization.

SOP's

Authentrics has developed and adhered to its own SOP's for designing and operating software. We can help create SOP's for your organization, and we can demonstrate to your customers that we follow those requirements when developing software for you.

FDA Audit Worthy

Having spent more than a decade developing applications for clinical trials, Authentrics knows how to prepare and maintain complete system documentation for both software development and ongoing operations. We were audited and approved as a vendor by several companies for conducting FDA supervised clinical trials, including Pfizer and the Harvard Clinical Research Institute (HCRI). We can prepare SOP's (Standard Operating Procedures) for your company, and follow them in our development process.