Briefs

Cyco Teams to Provide Part 11 Tool

Cyco Software, a company offering engineering data management solutions, has teamed with a global alliance of its Solution Partners to promote the new Cyco AutoManager industry module for the pharmaceutical industry, the company said.

Developed by DataCore Technology, the out-of-the-box FDA Module provides the technical controls needed to manage engineering documentation throughout the enterprise and be 21 CFR Part 11 compliant.

DataCore developed the module for the pharmaceutical industry to address specific data management needs.

Bridge Pharmaceuticals Hits Milestones

Bridge Pharmaceuticals, with the assistance of B-W Design Group and Instem, has successfully validated HVAC/BMS Systems and its Provantis data acquisition software for full Part 11 compliance, the company said Sept. 5.

Bridge, a preclinical contract research organization in Asia, announced that its preclinical testing laboratory in Zhongguancun Life Science Park in Beijing, China, has completed the first of two validation phases of all instrumentation, software and air handling and BMS systems.

The facility, one of the largest in China, is currently the only preclinical laboratory in China to have U.S. level GLP validated systems and software, the company said.

BioPassword Part 11 Solution Wins Award

BioPassword, a Seattle-based software company providing secure authentication and anti-fraud solutions, recently announced that Info Security Products Guide, a Silicon Valley Communications publication, has named BioPassword Enterprise Edition a winner of the 2006 Tomorrow’s Technology Today Award.

BioPassword helps compliance efforts with 21 CFR Part 11, among other regulations.

SunView Unveils New Tool

SunView Software, a provider of next-generation software solutions designed to enable companies to better track, manage and control IT change, just rolled out ChangeGear 2.0, the latest version of the company’s IT change management software. It features enhancements including a refined Web application, improved ad hoc reporting capability and new workflow automation, according to the company.

Getting a firm handle on change management is a critical component of erecord compliance programs, experts have repeatedly told PIR.

In addition to its advanced workflow, impact analysis, automatic notification and other capabilities, ChangeGear officials said the product reduces the cost and workload associated with regulatory compliance. For a data sheet or to view an online demo, log on to www.sunviewsoftware.com/.