The AVS140-6 is a complete system used to perform autoclave validations and autoclave temperature mapping. The AVS140-6 consists of six NIST traceable high temperature and pressure data loggers, an IFC406 Multiplexer Interface and the MadgeTech 4 Secure Software providing tools to users to assist with FDA 21 CFR Part 11 compliance.
The AVS140-6 kit includes:
(5) HiTemp140 High Temperature Data Loggers with 1 in probe style, all with NIST Calibration Certificates
(1) PR140-NPT High Temperature and Pressure Data Logger with an NPT port, with NIST Calibration Certificate
(1) IFC406 Multiplexer interface
(1) MadgeTech Secure Data Logger Software, complete with IQ/OQ/PQ validation protocols and workbook
The MadgeTech 4 Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. MadgeTech 4 Secure Software contains criteria such as electronic signatures, access codes, secure data files, and an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity.