Dear Regulatory Affairs,
I’ve spent my entire career working in and around FDA regulated medical activities. I know the frustration, anxiety and added expense one experiences preparing for and enduring an FDA inspection. Eight years ago I was overseeing cyclotron operations at a number of different facilities and anticipating that the FDA would eventually step up its oversight of cyclotron facilities. I began working with our software developers to create an electronic means to insure and document that our manufacturing processes represented best practices and would withstand FDA scrutiny.
In 2013, after many iterations and beta tests, we launched BioTrax QMS®. The software has been well received by a number of proactive leaders in our industries looking for a cost effective, electronic solution to facilitate the manufacturing process. I’m confident BioTrax QMS will soon emerge as the market leader for this type of software solution.
BioTrax QMS was developed and is supported by ec2 Software Solutions, the longtime market leader in nuclear medicine software. Our products, NMIS, BioDose, BioRx and RMIS are used in virtually every independent nuclear pharmacy (and all of their customers’ facilities) throughout the country as well as in Europe, Asia, Canada and the Middle East. We are the pioneers in providing electronic solutions to the industries we serve, dominating for over 30 years.
I’m enclosing information describing the specific features included in BioTrax QMS. If you feel our software might be of benefit in helping you deal with FDA oversight, and improve overall quality within your operations, please contact us and we will provide you and your team with a demonstration of the software’s capabilities. Call480-634-8736 or email firstname.lastname@example.org for further information.
Dr. Dennis Eshima, Ph.D. RPh. B. C. N. P
President ec2 Software Solutions