If you are a medical manufacturer, or are otherwise regulated by the FDA, then 21 CFR Part 11 is surely a growing concern of yours. Mattec is the leading supplier of real-time production and process monitoring systems to medical manufacturers, in part because we have helped so many customers to achieve compliance with FDA 21 CFR Part 11.

In 2002 and 2003, Mattec underwent a series of steps to perform a "gap analysis" for ProHelp® EPM, MIUs, and other areas. That gap analysis resulted in several development projects aimed at making changes to the product that would facilitate compliance with 21 CFR Part 11. Today's ProHelp® EPM software is the result of a series of deliberate steps designed to make it easier for you to achieve compliance with 21 CFR Part 11.

ProHelp® EPM automatically monitors every cycle of every molding machine in your plant and alarms when processes deviate from standards. ProHelp® EPM is capable of automatically qualifying 100% of parts without user interaction.

Additonally, ProHelp® EPM automatically records statistical samples of machine processes, 24 hours per day, 7 days per week, and can create exception logs for machine cycles that have processes operating outside of allowable standards. ProHelp® EPM can even divert parts that are made under out-of-limit process conditions, so inspectors can properly analyze those parts for accuracy and usability.

The Audit Trails option in ProHelp® EPM will automatically track changes to supported areas of the system and will provide a date/time stamp of each change and the name of the person who is responsible for making the change.

ProHelp® EPM is built on the Microsoft Windows 2000 operating system. Access to areas of the software are strictly controlled and take advantage of the security functionality that is built into Windows 2000.

A recent addition to the system, however, is the "MIU Security Option". This optional feature adds a similar level of security to MIUs. For example, with the MIU Security option, you get the following:

• MIU users must login with a valid ID and password.


• Failed login attempts are logged and available for display.


• Access to areas of the MIU software are restricted on a user-by-user basis.


• Users are automatically logged out after a specified period of inactivity.

Data that is collected by ProHelp® EPM can be kept on-line for easy retrieval. After being on-line for several years, this data can be backed up and stored offline for retrieval 5 or 10 years in the future.

An important step in achieving FDA compliance is for the customer to perform software validation testing on new releases of the ProHelp® EPM software. Fortunately, Mattec can provide you with test cases to help facilitate this testing.

We presently offer more than 700 test cases for you to use as part of your software validation process. And we can offer the technical expertise to help you implement this validation process.

Mattec has the technical expertise to help you implement your ProHelp® EPM system and can offer guidance on achieving 21 CFR Part 11 Compliance with your ProHelp® EPM system. We are experts in real-time production and process monitoring and can help guide you through installation, validation, and beyond.