Validation

All Konnexis products and control systems are subject to and must comply with a number of internal standards and FDA regulations. The FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

Konnexis Quality Assurance staff is experienced and trained in GAMP Good Practices (Validation of Process Control Systems) as well as test methods in accordance with AAMI and ISO standards. The GAMP Guide for Validation of Automated systems is a recognized standard for Good Automated Manufacturing Practice in the healthcare and pharmaceutical industries.

Our control systems and the documentation we provide to our customers has been subjected to a number of internal and FDA audits. As a result of these experiences, we have had the opportunity to verify and continuously improve our approach to documenting and testing the software.

The “V Model” serves as a good graphical representation of the allocation of various product specifications to their respective qualification measures. In other words, the left-hand branch represents system specifications resulting out of the planning process while the right-hand branch assigns required qualification measures against those left-hand specifications. The Deliverables are represented by the bottom of the V, where the branches meet.