Electronic auditing for 21-CFR-Part-11
This software module manages electronic records and signatures in compliance with Food and Drug Administration regulations.
AUDITTrak is a new software module for TrakSYS designed to provide electronic records and electronic signatures for all changes made to the production-related data in compliance with the Food and Drug Administration 21-CFR-Part-11. The module empowers pharmaceutical companies to undertake operational excellence initiatives with complete confidence in their data change management capabilities.
The module provides full electronic record-keeping capabilities both for the collected data, and the data collection configuration. It actively monitors and alerts changes to the existing infrastructure configuration, setpoints, products, and recorded values. Such changes trigger alerts and the need for authorization via multi-layer electronic signatures. Whenever a change is made, AUDITTrak mandates verification from two sources in the form of electronic signatures along with relevant notes to describe the reason for the change. All changes are recorded for detailed reporting and analysis. Authorized users can query and filter audit trails for reporting via the TrakSYS knowledge management portal, WEBTrak.
Parsec Automation Corp.
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Annual Salary Survey
Before the calendar turned, 2016 already had the makings of a pivotal year for manufacturing, and for the world.
There were the big events for the year, including the United States as Partner Country at Hannover Messe in April and the 2016 International Manufacturing Technology Show in Chicago in September. There's also the matter of the U.S. presidential elections in November, which promise to shape policy in manufacturing for years to come.
But the year started with global economic turmoil, as a slowdown in Chinese manufacturing triggered a worldwide stock hiccup that sent values plummeting. The continued plunge in world oil prices has resulted in a slowdown in exploration and, by extension, the manufacture of exploration equipment.
Read more: 2015 Salary Survey