If you've ever worked with CFR 21 Part 11 validation, you know that there are many requirements for handling of data, user access, audit trails, and configuration tracking. Cal-Bay Systems of San Rafael, CA recently developed several automated systems for Medtronic Vascular Division and Tyco Healthcare with software tools that facilitated the validation process. Cal-Bay used software techniques to ensure CFR 21 Part 11 compliance including:

- Integrating CD-ROM burn of test data seamless to the user

- User Level Login with Password Protection

- Providing change tracking with audit trail for all configuration screens

- Providing a fully functional calibration executive for ensuring calibrated sensors

- Configuring control PC to eliminate Windows functionality and prevent users from accessing information

"Over the last year, we have improved our ability to develop and deliver systems for CFR 21 Part 11 compliance." Says Dave Weisberg, Regional Manager of Cal-Bay's Northern California office. "We have added significant capabilities to our ability to serve the Medical Device and BioMedical markets".

About Cal-Bay Systems

Cal-Bay Systems of San Rafael, CA is a leader in automation systems engineering and a Select Integrator in the National Instruments Alliance Program. Cal-Bay specializes in the design, development, installation, training, and support of automation systems for commercial applications. Cal-Bay mainly works with Fortune 500 companies such as Applied Materials, Honeywell, IBM, Lockheed, and Medtronic. Cal-Bay has achieved significant growth since 1993 and currently has 2 offices in California and an offshore development center in Bangalore India.