Related Manuals for MadgeTech AVS140-1
Summary of Contents for MadgeTech AVS140-1
- Page 1 Product User Guide AVS140-1 Autoclave Validation Data Logging System To view the full MadgeTech product line, visit our website at www.madgetech.com.
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Page 3: Table Of Contents
Maintenance ............10-11 Autoclave Validation 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 and the MadgeTech 4 Secure Software providing tools to users to assist with FDA 21 CFR Part 11 compliance. -
Page 4: Hardware
Hardware HiTemp140 Product Overview High Temperature Data Logger The HiTemp140 data logger is MadgeTech’s solution for high precision, rugged temperature monitoring. It can withstand temperatures from -40 °C to 140 °C and has an accuracy of ±0.1 °C. The HiTemp140 can store up to 32,700 readings, and features a rigid external probe capable of measuring extended temperatures, up to 260 °C (500 °F). -
Page 5: Hardware
Hardware IFC400 Product Overview Interface Cable Package 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. IFC400 Specifications -20 °C to +50 °C (-4 °F to +122 °F) Operating Environment:... -
Page 6: Software
Software MadgeTech 4 Secure Software 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. -
Page 7: Software
Great New Features The MadgeTech 4 Secure Software is a powerful, intuitive tool containing features that are designed to save on both time and headaches. Both management and users will find MadgeTech’s new software exciting: users will love the familiar interface and numerous shortcuts, while management will appreciate the increased data security and time-saving elements. -
Page 8: Iq/Oq/Pq Validation Protocol
This enormous time and money saving feature eliminates the need to develop in-house software validation procedures. The MadgeTech IQ/OQ/ PQ protocol is in support of FDA and cGMP guidelines. In addition, MadgeTech offers a Software Validation Workbook to help the user verify the functionality of the software. -
Page 9: System Installation
5. Installing the MadgeTech 4 Secure Software Click on MadgeTech Secure Software and then select Install MadgeTech Secure Software. Follow the MadgeTech 4 Secure Setup Wizard on-screen prompts to complete the installation. The installation of MadgeTech 4 Secure Software is complete! Connecting the Data Logger Interface 1. - Page 10 By default this is set to seven days prior to calibration due date and can be changed by the user by going to the File tab in the MadgeTech 4 Secure Software and clicking on Options. Select Device and check “Display popup notification when a device nears its next calibration date”.
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Page 11: Maintenance
7. Tightly screw the data logger back together until the O-Rings are no longer visible. Maintenance: MadgeTech data loggers come directly from the factory with high quality O-Rings that have been properly installed. As a user, there are only a few things that need to be remembered to maintain a functional O-Ring seal. - Page 12 MadgeTech, Inc. . 6 Warner Road . Warner, NH 03278 Tel: (603) 456-2011 . Fax: (603) 456-2012 . info@madgetech.com . www.madgetech.com DOC-1293-036-00 Rev2 2014.10.30...