by Jason Cooper, Vice President and Director - Health and Life Sciences Mid-Atlantic Technology, Research, and Innovation Center (MATRIC)

Software Assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other medically-oriented life-critical systems.

Read the full article here.

For more information about MATRIC, please visit their website at www.matricresearch.com

The Institute for International Research will be holding its 3rd Annual Pharma IT Congress on September 26-28, 2006 in Princeton, New Jersey. Senior executives from across the industry will come together for this prestigious event in an open forum to discuss how IT can strategically become a true business partner in achieving top-line corporate growth. Led by industry thought leaders, the three-day conference will include over 17 sessions and hands-on workshops covering topics that range from Business Service Management and IT/Business Alignment to Data Mining and Data Flow Modeling.

Added highlights for 2006 include an innovative afternoon champagne roundtable break-out session, where members from the industry can informally re-group to candidly explore niche topics like cost and contract management in IT, Sponsor-Vendor selection processes, and knowledge management. Additionally, LSIT will be facilitating an exclusive executive briefing immediately following the close of the conference, open to all participants.

Mira Milovancev, Working Group Leader for the GIP Guidance Document on the Validation and Verification Chapter is top notch. Mira has her own consulting service, Mira CLE where she brings 20+ years of knowledge and first hand experience in medical systems and devices. Her heart is in engineering, I think she keeps a tool kit in her purse. Yet her depth and breadth of experience in validation, verification and compliance are great. She has managed the best and worst (including audits and warning letters, pending consent decrees — that usually brings a few heart palpitations) situations to success.

We are honored and grateful to have Mira lead a team of over 15 volunteers for developing and writing content in the Validation Chapter. No dust has gathered on her feet as she developed the outline, had FDA review it, and deployed the team into action within 3 weeks. She has surmounted any and all diverse and complex areas of validation through her attention to detail and pulling together the brilliance and expert knowledge of this working group. It is heartening to see the progress and energy this Working Group has. Thank you Mira.

We are pleased to announce that the IRS has qualified LSIT as a 501(c)(3) non-profit public charity. This means that contributions to us are "tax deductible under section 170" of the Internal Revenue Code. It also means that we are qualified to "receive tax deductible bequests, devises, transfers or gifts under section 2055, 2106 or 2522 of the code."

We're not sure what that second part means, but we like the way it sounds.

ProSanos Corporation, specialists in the capture, integration, and analysis of healthcare-related data, was selected to receive a grant from the Pharmaceutical Research and Manufacturers of America (PhRMA) to study drug safety. The grant supports the use of ProSanos' Pharmacovigilance Maps (PVmaps™) technology to study methods for detecting drug safety signals in spontaneous reporting databases. Such databases - used by patients, physicians and other healthcare providers to voluntarily report suspected drug-related adverse events - are an important, but limited and sometimes flawed, source of information about drug safety.

You can read the full press release here.