COVINGTON, LA. — Allpax, a ProMach brand, now offers a digital chart recorder to replace the paper-based systems still used for sterilization records with most retort systems. This new universal solid-state digital recorder from Allpax offers safe and secure data storage, is compatible with both batch and continuous retorts, and is fully compliant with the regulatory requirements of 21 CFR Part 11 for electronic record keeping.
The presentation of the electronic data and the printed data is specifically designed to improve the record review process by reducing risk and increasing 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.
The system is compatible with both electronic record keeping systems as well as legacy record printing systems. When connected to a printer, the device can automatically print the process record trends to a paper report at the end of each batch allowing it to serve as the official Temperature Recording Device (TRD). For those processors 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 new device from Allpax records real-time data and graphically displays it in a user-configurable format. Custom definable ranges, scales, and chart graduations optimize legibility and adhere to the best practices described under 21 CFR Parts 113 and 114. The device also offers customizable on-screen notifications and alarms with the ability to send these messages via e-mail.
The Allpax digital recorder stores electronic records in a secure Microsoft SQL server database. Password security with fingerprint traceability of all device interactions ensures data integrity.
Allpax will be demonstrating its new digital chart recorder live at PACK EXPO, scheduled from Sept. 27 to 29 in Las Vegas, at booth 3429.
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