MDT Software and Stelex join forces to deliver bulletproof Automation Change Management solutions
Bensalem, PA September 1, 2006 - Stelex, a firm providing enterprise compliance solutions to regulated industries and MDT Software, developer of AutoSave, the industry's most advanced software for tracking changes in industrial programmable devices, today announced a strategic alliance to provide quality solutions for companies requiring firm adherence to FDA regulations.
The computer programs inside devices such as programmable logic controllers, robots, and numerically controlled machines that power the manufacture of drugs and medical devices are considered electronic records under 21 CFR Part 11. Comprehensive audit trails of any activity involving code changes and obsolete versions of code must be maintained for audit purposes.
Implementation of a system like AutoSave in a FDA regulated environment must follow meticulous quality system procedures where computer system validation is the basis of the project lifecycle. With the enhanced reporting tools in AutoSave version 5.03 and Stelex's rich tenure in the regulated space, audit readiness and product safety is assured.
This alliance will allow Stelex and MDT to take a leadership role in Automation Change Management solutions for the Life Sciences industry by coupling the best technologies with proven industry know-how and methodologies.
About MDT Software
MDT Software is the world leader in change management solutions for automated manufacturing devices. MDT's flagship product, AutoSave, is an enterprise source management solution to protect, save, restore, discover, and track changes in industrial programmable devices and documents. AutoSave is used by over 4,700 end users to effectively manage change and minimize downtime associated with plant floor automation. AutoSave supports the most comprehensive range of devices and editors in the industry. MDT's primary markets are: automotive, pharmaceutical, food & beverage, mining, petrochemical, utilities and specialty discrete manufacturing. MDT is based in Alpharetta, Georgia and has installations worldwide.
To learn more about MDT Software, go to
www.mdtsoft.com