Paperless trail: Parsec automation unveils electronic audit solution

Parsec Automation Corp., a supplier of real-time performance management solutions, has released a new application that can create electronic records and signatures for all changes made to the production-related data. The solution—called AUDITTrak—will ensure a company’s compliance with the Food and Drug Administration (FDA) 21 CFR Part 11.

02/29/2008


Parsec Automation Corp ., a supplier of real-time performance management solutions, has released a new application that can create electronic records and signatures for all changes made to the production-related data.

The solution—called AUDITTrak—will ensure a company’s compliance with the Food and Drug Administration (FDA) 21 CFR Part 11. AUDITTrak is a new module within Parsec’s TrakSYS software suite.

TrakSYS is a continuous improvement and knowledge management solution that helps pharmaceutical, medical device, biotech, and food & beverage manufacturers with the implementation of process analytical technology (PAT) framework—a set of FDA guidelines for

The new AUDITTrak module should allow pharmaceutical companies to undertake operational excellence initiatives with complete confidence in their data change management capabilities. AUDITTrak actively monitors for changes to the existing infrastructure configuration, set points, 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 also can query and filter audit trails for reporting via the TrakSYS knowledge management portal, known as WEBTrak.

“In today’s ever-changing world of compliance and regulatory standards, users of performance management systems must have the assurance that compliance with FDA regulations is preserved should changes to data impact current good manufacturing practices,” says Scott Klages, VP and senior manufacturing consultant, Parsec Automation. “Parsec’s AUDITTrak provides users with full electronic record-keeping capabilities both for the collected data, and the data collection configuration.”





No comments
The Top Plant program honors outstanding manufacturing facilities in North America. View the 2015 Top Plant.
The Product of the Year program recognizes products newly released in the manufacturing industries.
The Engineering Leaders Under 40 program identifies and gives recognition to young engineers who...
World-class manufacturing: A recipe for success: Finding the right mix for a salad dressing line; 2015 Salary Survey: Manufacturing slump dims enthusiasm
2015 Top Plant: Phoenix Contact, Middletown, Pa.; 2015 Best Practices: Automation, Electrical Safety, Electrical Systems, Pneumatics, Material Handling, Mechanical Systems
A cool solution: Collaboration, chemistry leads to foundry coat product development; See the 2015 Product of the Year Finalists
Digital oilfields: Integrated HMI/SCADA systems enable smarter data acquisition; Real-world impact of simulation; Electric actuator technology prospers in production fields
Special report: U.S. natural gas; LNG transport technologies evolve to meet market demand; Understanding new methane regulations; Predictive maintenance for gas pipeline compressors
Cyber security cost-efficient for industrial control systems; Extracting full value from operational data; Managing cyber security risks
Getting ready for industrial IoT; Visualizing the (applied) automation continuum; Preventing VFD faults and failures; Using wireless for closed-loop applications
Migrating industrial networks; Tracking HMI advances; Making the right automation changes
Understanding transfer switch operation; Coordinating protective devices; Analyzing NEC 2014 changes; Cooling data centers

Annual Salary Survey

After almost a decade of uncertainty, the confidence of plant floor managers is soaring. Even with a number of challenges and while implementing new technologies, there is a renewed sense of optimism among plant managers about their business and their future.

The respondents to the 2014 Plant Engineering Salary Survey come from throughout the U.S. and serve a variety of industries, but they are uniform in their optimism about manufacturing. This year’s survey found 79% consider manufacturing a secure career. That’s up from 75% in 2013 and significantly higher than the 63% figure when Plant Engineering first started asking that question a decade ago.

Read more: 2014 Salary Survey: Confidence rises amid the challenges

Maintenance and reliability tips and best practices from the maintenance and reliability coaches at Allied Reliability Group.
The One Voice for Manufacturing blog reports on federal public policy issues impacting the manufacturing sector. One Voice is a joint effort by the National Tooling and Machining...
The Society for Maintenance and Reliability Professionals an organization devoted...
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
Maintenance is not optional in manufacturing. It’s a profit center, driving productivity and uptime while reducing overall repair costs.
The Lachance on CMMS blog is about current maintenance topics. Blogger Paul Lachance is president and chief technology officer for Smartware Group.
This article collection contains several articles on the vital role that compressed air plays in manufacturing plants.