MadgeTech AVS140-1 Autoclave Validation Data Logging System

Madgetech AVS140-1 – Autoclave Validation Data Logging System

The AVS140-1 is a complete system used to perform autoclave validations. The AVS140-1 consists of a high temperature data logger, an IFC400 Interface Cable and the MadgeTech 4 Secure Software providing tools to users to assist with FDA 21 CFR Part 11 compliance.

The HiTemp140 is a rugged, high precision, temperature data logger that is built for use with autoclaves and harsh environments. This stainless steel device is submersible, can withstand temperatures up to 140 °C (284 °F) and has an accuracy of +/-0.1 °C (0.18 °F).

The IFC400 is an Interface Cable Package for the HiTemp140 Data Logger. Included with the package is a USB Connection Cable and Docking Station Cradle. The IFC400 Data Logger Interface allows for a device to be connected to a PC.

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.

MadgeTech provides on-site IQ/OQ/PQ services to help the user validate the data logging system. Our trained staff are extremely knowledgeable with the standard IQ/OQ/PQ protocols of the MadgeTech data logging system. This service is a cost-effective means to save time and ensure proper implementation of IQ/OQ/PQ of the MadgeTech data logging system with a minimal disruption to staff and operations. Get more information on our IQ/OQ/PQ On-Site Service.