Welding software tracks changes

Add-on software makes ultrasonic welders compliant to FDA standards CFR 21 part 11 for login and traceability. The FDA System Component features login screens that let only authorized personnel operate the system, with administrator, supervisor, setup, and users defined to allow access to different features of the Dialog touch-weld process controller. The software creates an audit trail, or electronic record that shows all user changes made and associated electronic signatures.

Herrmann Ultrasonics Inc., 620 Estes Ave, Schaumburg IL 60193, (847) 985-7344, info.ims.ca/6172-289
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Proxy feature keeps projects moving

TrackWise software assists with quality management, regulatory affairs, environmental health and safety, and Sarbanes-Oxley compliance. A recent feature, called the “proxy,” lets users designate others to perform actions and activities on their behalf. The proxy user then has all rights to perform scheduled activities and edit records for the designator.

Sparta Systems Inc., Holmdel Corporate Plaza, 2137 Highway 35, Holmdel, NJ 07733, (888) 261-5948, info.ims.ca/6172-293
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Streamlining the collection of compliance info

Compliance Process Management software helps life science companies ensure that compliance information is received immediately, addressed professionally, and implemented effectively. An Event Manager module consolidates customer complaints, product nonconformances, deviations, and out-of-specifications. A Batch Manager electronically monitors master batch records and production processes to detect delays, reduce cycle time, and improve material flow control and efficiency. And a Change Manager improves quality-control calibration, maintenance, audits scheduling, and links to installation qualification protocols for equipment.

QS Labs Inc., 5 Park Plaza, Suite 1550, Irvine, CA 92514, (949) 862-5000, info.ims.ca/6172-290
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Internal inspections and FDA compliance

Aris Audit Manager 3.0 is a Web-based workflow system that baselines, tests, and certifies internal control systems. It helps organizations document their business processes and comply with legal requirements and guidelines such as the Sarbanes-Oxley section 404-certification. New features of version 3.0 include automatic workflow configuration, a comprehensive escalation and sign-off management system, and data transfer capabilities from a range of source systems.

IDS Scheer Inc., 1055 Westlakes Dr, Suite 100, Berwyn, PA 19312, (800) 810-2747, info.ims.ca/6172-291
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PLM ensures regulatory compliance

Agile 9.2 product-lifecycle management (PLM) software comprises compliance, product portfolio, collaboration, and quality-management modules. The Product Governance and Compliance module ensures organizations meet environmental standards such as WEEE and RoHS. The Product Portfolio Management module works with Microsoft Project and includes analytics such as time to market, and program and issues tracking. The Product Collaboration module lets stakeholders in the extended design and supply chain access product data such as bills of material and work instructions.

Agile Software Corp., 6373 San Ignacio Ave., San Jose, CA 95119, (408) 284-4000, info.ims.ca/6172-294
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