The Reality of Medical Software Compliance
Penticton, B.C. (January 19, 2010) – SageKey Software Inc. today announced the publication of Kent Matthies’ article The Reality of Medical Software Compliance in both the Bio-IT World digital magazine and the eCliniqua newsletter.
The article outlines the current state of medical software compliance in the United States of America and highlights some of the major concerns hovering around the medical and software development industries. To read the article in its entirety, please go to http://www.ecliniqua.com/2010/01/19/sagekey.html
Bio-IT World is a trusted source of information for every aspect of bio-technology. The Cambridge Healthtech Institute publishes the magazine only a handful of times each year, making the opportunities for publication limited and the competition fierce. Being published in such a respected magazine was a big honor for SageKey.
Kent Matthies has been a project manager and lead developer with SageKey for over ten years. Some of the notable projects that Kent has spear headed are Cardiovascular Goal Manager (CVGM), SEGManager, BizLink and Dialysis Data Manager. His ambition, drive and superb eye for detail ensure that all the projects in which he is involved exceed customer’s expectations.
SageKey Software Inc. was founded in 1996 and now has over 3500 customers in more than 50 countries worldwide. They provide a variety of services ranging from installation tools for Access developers to custom development of FDA and HIPAA regulated medical software.
Professional Installs Made Easy for Microsoft Access Developers
Penticton, B.C. (August 24, 2009) – SageKey Software Inc. today announced the release of the SageKey Access Deployment Wizard, the latest innovation in their suite of products that help Microsoft Access developers create professional, worry free installs.
The SageKey Access Deployment Wizard provides developers with an easy to use, step by step interface that guides them through creating a seamless install for their end user. Developers can also sleep easier knowing that their customers will never again have to deal with pesky and time wasting Access Repair messages because installations created with the Deployment Wizard automatically handle this frustrating problem.
“We’ve spent a lot of time listening to our customers,” said Steve Bailey, Products and Services Manager at SageKey. The Access Deployment Wizard provides a lot of additional functionality including compatibility with Windows 7 and Office 2010, extra installs before and after the main install, and extra shortcuts.
Not only does the latest software from SageKey provide more functionality than ever before, but they have also dropped the price in an effort to make it accessible to even more Access developers. Steve Bailey explains how this is possible, “We have added a version of our security tool to the product so that we can control licenses better, avoid piracy and therefore keep our prices down.”
SageKey Software Inc. was founded in 1996 and now has over 3500 customers in more than 50 countries worldwide. They provide a variety of services ranging from installation tools for Access developers to custom development of FDA and HIPAA regulated medical software.
SageKey Software Awarded Letter of Compliance
Penticton, B.C. (July 20, 2009) – SageKey Software Inc. today announced the acceptance of a Letter of Compliance, recognizing their adherence to 21CFR Part 11 and HIPAA regulations, from David Nettleton of Computer System Validation.
In the United States, computer software that contains patient medical data is governed by the Health Insurance Portability and Accountability Act (HIPAA) and may additionally be governed by Title 21 of the Code of Federal Regulations Part 11. These regulations are in place to protect patient data and specify guidelines and rules for various aspects of medical software.
“SageKey shows an excellent level of compliance related to FDA and HIPAA regulations and is a mature contract software development vendor,” states David. These words resonate well in the ears of SageKey President Barry Matfield, “The letter of compliance comes at a great time. We are currently positioning ourselves to make a big splash in Medical Software Development sector in the United States.”
David Nettleton is one of the United States foremost experts on computer system validation for 21CFR Part 11, has co-authored three books on the subject, and has completed more than 177 software validation projects. “On average I evaluate 10 companies a year,” explains David, “Out of all the software vendors (you have to have a product for certification) only 6 have passed for a compliance letter.”
SageKey Software Inc. was founded in 1996 and now has over 3500 customers in more than 50 countries worldwide. They provide a variety of services ranging from installation tools for Access developers to custom development of FDA and HIPAA regulated medical software.