This digital device offers safe and secure data storage, fully compliant with the regulatory requirements of 21 CFR Part 11 for electronic record keeping.
When connected to a printer, the device can be setup to automatically print the process record trends to a paper report at the end of each batch period, thus allowing it to serve as the official Temperature Recording Device (TRD) in both electronic record keeping systems as well as legacy record printing systems. The presentation of the electronic data and the printed data is specifically designed to improve the record review process and thus reduce risk and increase efficiency in the review process. Additionally, the digital chart recorder eliminates the typical process deviations caused by print skipping, improper paper installation, and the other issues associated with mechanical chart recorders.
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Installation is easy – simply move the wires from the mechanical device to the new Allpax digital device. For those migrating toward electronic record keeping, the Allpax digital recorder can be installed alongside an existing pen-and-paper recorder and function as an electronic backup. This Allpax solution eliminates paper-chart deviation issues caused by paper jams, skips, dry ink, pen adjustments, paper replacement, and incorrect paper installation.
The Allpax digital chart recorder is compatible with both batch and continuous retorts. This device records real-time data and graphically displays it in a user configurable format. Each input parameter can be displayed clearly and understandably. Custom definable ranges, scales, and chart graduations optimize legibility and adhere to the best practices described under 21 CFR Parts 113 and 114. The Allpax digital chart recorder stores electronic records in a secure Microsoft SQL server database. Password security with fingerprint traceability of all device interactions ensure data integrity. The device also offers customizable on-screen notifications and alarms with the ability to send these messages via e-mail.