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News

MadgeTech releasees Secure Software for FDA 21 CFR Part 11 compliance

MadgeTech : 14 January, 2008  (New Product)
MadgeTech has released Secure Software to enable compliance with FDA 21 CFR Part 11 requirements.
With high data and user security and traceability features, the MadgeTech Secure Software adheres to standards in which electronic files are considered equivalent to paper records. The advanced software incorporates features such as electronic signatures, access codes, secure data file, and audit trail.

MadgeTech Secure Software was developed specifically to help meet regulations and working practices designed to ensure high security standards, in accordance with GAMP (IQ/OQ/PQ) and enforced by the FDA and other regulatory bodies.

The user-friendly software features an automatic Audit Trail which displays information such as user log-in/log-out times, files downloaded, saved, printed and such like. Each record is date and time stamped, in addition to including user information. The software also features electronic signatures, which contain the printed name of the signer, date and time of signing and meaning of the signing.

MadgeTech Secure has a layout similar to the standard software, allowing users to easily learn the additional features. It is compatible with all MadgeTech data loggers, and can be run on a PC with Windows 95, 98, NT, 2000, XP and Vista. MadgeTech Secure is priced at $1,000.00 per computer for unlimited users.


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