We have had a very positive experience dealing with all of the Novatek staff. They are very knowledgeable professionals, who make a concerted effort to satisfy customer needs. Our IT department was impressed with the way they handled the software installation and IQ/OQ validations. My technical staff found it easy to learn the basic use of the software, although we are still "discovering" tools that we did not notice at first. The Novatek technical representative has been extremely helpful whenever we asked for assistance, and especially in giving us different approaches to entering some of our unusual test protocols for easier data analysis.
This module is great for scheduling, tracking, and electronically approving stability test data. The trending feature and Arrhenius estimates of shelf-life have worked well for us, and several of our reports have been favorably reviewed by the FDA. Multiple lots can be selected to trend in the same graph. The software also offers ample flexibility for creating individualized report formats. Another nice feature is the modular construcion of the database which allows you to establish a number of different test protocols, which then can be selected for future studies without re-entering all of the specific details of the test plan.
(Changing a con into a pro): We knew at the outset that the module was not designed for multiplex data (Our DNA typing and Ab detection tests measure ~100 analytes simultaneously, with mixed high and low experimental values due to oligo probe or DNA sample variability, Ab avidity/titer and individual specificity). Initially we utilized the software to analyze only selected parameters (expected positive reactions). Later, through in depth discussions with the Novatek technical and programming staff, we co-developed a customized approach to overcome these limitations. I think this will result in a unique analytical tool for trending and analyzing mutivariate stability data from complex assays using mutiplex platforms.
would recommend to anyone looking for Laboratory Information mangement system and Quality Management system
very user friendly and function rich
we were overall satisfied
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