Autoclave Validation System: Includes (1) HiTemp140 data logger with Calibration certificates, IFC400 interface cable, (1) license MadgeTechs FDA 21 CFR Part 11 Secure Software and IQ/OQ/PQ validation protocols.
The AVS140-1 is a complete system for performing autoclave validations and assisting users with 21 CFR Part 11 compliance. Includes ISO17025 accredited calibration certificate.
The AVS140-1 Includes:
- (1) HiTemp140: High Temperature Data Logger with 1 in. Probe and Calibration Certificate
- (1) IFC400: Interface Cable
- (1) MadgeTech Secure Data Logger Software Complete with IQ/OQ/PQ Validation Protocols and Workbook
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The HiTemp140 is a high precision, temperature data logger built for use in harsh environments. This stainless steel device is submersible and can withstand temperatures up to 140 °C (284 °F) with an accuracy of ±0.1 °C (0.18 °F).
The MadgeTech 4 Secure Software aids customers in compliance with 21 CFR Part 11 requirements, ensuring 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 to meet requirements while providing data integrity.
