Briefs
Paxonix Joins EMC Documentum Program
Paxonix, a MeadWestvaco subsidiary and provider of brand and packaging asset management and workflow software, last week announced that it had joined the EMC Documentum Application Developer Program.
As a member, Paxonix will receive specialized design consultation and guidance, along with access to dedicated EMC technical resources to ensure that the integration of PaxPro into EMC Documentum software meets quality standards.
Supporting more than 400 file types, Paxonix is working with the Application Developer Program team to develop a “Designed for EMC Documentum” solution for the EMC Documentum content management platform.
With the integrated solution enterprise, customers will be able to manage their large, complex graphic labeling, packaging and compliance projects in PaxPro and then automatically transmit the finished work to a central EMC Documentum repository.
Customers with existing EMC Documentum implementations can continue to leverage EMC Documentum’s content management capabilities, while now using the specialized tools PaxPro provides.
PaxPro, a software solution customized to meet the packaging and branding needs of enterprise marketing and packaging departments, uses a best practices approach to packaging, labeling and compliance. The software, delivered as a service, ensures compliance with 21 CFR Part 11, PaxPro said in an Oct. 2 release.
To learn more about the EMC Documentum Developer Application Program, go to emc.com/applicationportfolio.
Endologix Taps MasterControl
MasterControl said last week that Endologix, a developer and manufacturer of minimally invasive treatments for vascular diseases, has chosen the MasterControl software solution to optimize its quality management system and boost its FDA compliance efforts.
Endologix, based in Irvine, Calif., is focusing on the development and marketing of its patented technology for the treatment of abdominal aortic aneurysms (AAAs), which affect approximately 1.7 million people in the U.S.
The company’s Powerlink System, approved by the FDA in 2004, is a one-piece endoluminal stent graft used in treating AAAs. Endologix wanted to streamline its document change order process and automate its training control process, according to William Wolenchuk, the company’s document control manager.
The company looked at 10 software solutions before choosing MasterControl. Endologix is in the process of implementing the MasterControl quality suite, consisting of MasterControl Documents, MasterControl Forms and MasterControl Training.
Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic recordkeeping systems. MasterControl will be helping Endologix with its validation project by providing installation qualification and operational qualification protocols and a validation toolkit, which includes standard operating procedures, templates and risk assessment forms.
TeachMeIT Rolls Out New Courses
TeachMeIT, a provider of online courses in IT and desktop applications, has announced the launch of its Online Life Science Course Portal, which offers a life science course catalog.
The portal is focused on life science education for healthcare professionals, lab suppliers and members of pharmaceutical, biotechnology and instrument companies. It also offers patient education.
With more than 200 courses, the online library is divided into three disciplines: therapeutic, biotechpharmaceutical technology and regulatory and compliance.
All life science courses are SCORM 1.2 compliant and have been integrated with 21 CFR Part 11 compliant LMS applications, the company said.
For more information on courses, visit: lifescience.teachmeit.com/Courses.asp.
Partners Unveil New RFID Tool
Intelligent Devices, a subsidiary of Information Mediary, in partnership with American Thermal Instruments (ATI), just announced the official product launch of their RFID temperature tracker to pharmaceutical cold chain customers.
The Log-ic Temperature Tracker (www.log-ic.com) was presented at the 4th Annual Cold Chain Distribution for Pharmaceuticals, the only global forum for discussions on temperature controlled packaging, shipping, distribution and storage of pharmaceuticals and biopharmaceuticals, held last month in Philadelphia.
RFID Log-ic Temperature Tracker tags support CFR 21 Part 11 solutions and are promising to facilitate better control over the pharmaceutical cold chain at a lower cost, Intelligent Devices said in a Sept. 25 release.
Throughout the past year, Log-ic has been tested extensively in early adopter trials for transoceanic monitoring with industry leaders such as Sanofi, and La Croix Rouge (the French Red Cross). Log-ic is a light (under 1 oz.), thin (0.1 inch) and flexible RFID sensor tag capable of processing up to 64,000 readings per trip.