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LogBook 21 CFR Part 11 EDM Materials Management

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Paper-free Maintenance Tracking for the Pharmaceutical Industry

LogBook provides online maintenance tracking for pharmaceutical companies without the headache.

Tracking maintenance activities has taken on a new importance, with stricter regulatory requirements and operations being expected to perform more than ever. Operation professionals need to be able to pinpoint what task was performed when- many times at a moment’s notice. And regulatory agencies need more than just the data. Data must be assembled for presentation, often with each agency requiring reports in their own specific format.

Online maintenance tracking systems offer considerable benefits over paper-based records and they are quickly becoming a necessity for operations of the 21st century. Paper records take too long to search and are simply insufficient for users that need to access maintenance data from other parts of the operation and different company sites. More than that, paper records don’t allow users to access current data- a necessity.

LogBook gives pharmaceutical operations the means to stay on schedule and produce real-time reports in various formats. Professionals use scanners to record maintenance activity as it occurs. The scanners transmit data back to the information system. With proper password, users can access current data from any computer equipped with a Web browser.

MAX LogBook components

  • Handheld scanners

  • Bar code label printers

  • Web-enabled PC application

Integrated Bar Code Scanners

  • Fast, accurate data entry at the source.

  • Lightweight, easy to carry.

  • No manual data entry.

  • Palm-based scanner interface is easy to use and intuitive with pull-down menus to ensure accuracy.

  • Simple synchronization with the PC via the HotSync button on the scanner.

  • Choice of batch scanners, RF wireless scanners or cellular wireless scanners.

Bar Code Labels

  • Designed to work with existing bar code labels.

  • MAX can provide pre-printed labels.

  • Integrated bar code printing can be used to customize and print your own labels.

Printers

  • Online print management

  • Customized for your operation

LogBook Reporting/Web Reporting

  • View real-time operation data from any computer equipped with a Web browser.

  • Create data views specific to your needs via our powerful filtering capability.

  • Manage product data on screen in different formats and export to HTML, RTL, Microsoft Excel or text.

  • Client/Server system

  • Robust Oracle Server

Security and Accountability

  • Individual logins and a detailed change log ensures high-level accountability.

  • Three user security levels enable you to determine the proper access level for each user.

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Copyright © 2008 Manufacturing Applications eXperts, Inc.
Last Modified: 11/06/2008