Sparta Systems Announces That PPD Selects TrackWise® Quality Management Software

Hamilton, NJ Oct 30, 2012 – Sparta Systems, Inc., the market leader in enterprise quality and compliance management solutions, today announced that Pharmaceutical Product Development, LLC (PPD) has chosen TrackWise as its quality management system. PPD will use the software to centralize the management of its global quality and compliance processes, including audits and Corrective and Preventive Actions (CAPAs). PPD is a leading global contract research organization (CRO) providing drug discovery, development and lifecycle management services with offices in 46 countries.
In addition to its centralized administration, the Web-based Enterprise Quality Management System provides scalability to meet PPD’s future growth needs. Many of PPD’s pharmaceutical, biotechnology and medical device clients use TrackWise to manage their own quality management processes, offering PPD a high level of compatibility with its clients. TrackWise also easily integrates with PPD’s existing systems to ensure continued flow of processes across the entire organization.
“The TrackWise software allows us to build upon our electronic quality management operations by further integrating and globalizing our quality-focused processes,” said Neil McCullough, Ph.D., vice president of global quality and compliance at PPD. “Technology is playing a larger role in managing global quality operations, and this software will enable us to create customized solutions and increase efficiencies for our clients, saving them valuable time and money.”
Sparta Systems has experience working with global CROs, and PPD will leverage Sparta Systems’ best-of-breed technology to deliver centralized, consolidated quality management tracking, workflow management and regulatory reporting across the globe. PPD will use TrackWise for CAPA and audit management for Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
“The TrackWise solution was designed with the configurability to help diverse service organizations like PPD meet the expanding needs of their businesses,” said Michael Jovanis, vice president, product management, Sparta Systems. “We are confident that with TrackWise, PPD will meet its needs for enterprise-level, global quality management and compliance.”

IMG and ACM Provide International Travel Guidance In Light of New Viruses Discovered

Indianapolis, IN Oct 25, 2012 – With the recent emergence of several new human viruses, including a SARS-like coronavirus originating in Saudi Arabia, International Medical Group®, Inc. (IMG®), a worldwide leader in designing, distributing and administering global health care benefits, is addressing concerns from international travelers and customers.
Since the 2003 SARS outbreak, in which the virus claimed more than 900 lives worldwide, awareness and concern throughout the international community regarding viral infections and communicable diseases has been on the rise. Moreover, with recent reports of several new viruses affecting human populations, many international travelers are worried. However according to Dr. Jon Hart, Chief Medical Officer at Akeso Care Management®, Inc. (ACM®), IMG’s in-house URAC accredited, medical management service division, the international medical community has vastly improved its detection of and response to diseases of this nature, since the SARS outbreak. In 2005 the World Health Organization (WHO) drafted new International Health Regulations that require participating countries to immediately report disease outbreaks to the WHO, and to develop detailed plans-of-action and response capacities.
“Even with improved international coordination and communication, there are still some commonsense tips that can help travelers prepare for a trip and possibly prevent illness while traveling,” said Dr. Hart. “Practicing good hygiene is one of the most important measures. Washing your hands, avoiding close contact with others who are sick, and covering your mouth and nose when coughing or sneezing; are all considered good standards of care and basic steps travelers can take to avoid illness.”
IMG and ACM offered the following additional tips:
Review current travel warnings and recommended vaccinations for different countries. www.healthmap.org/en/ is an informational site that lists current warnings and communicable disease information.
Keep your medicines with you at all times. Do not check them in your luggage and do not leave them out in the open in your hotel room.
If there is any question about the quality of the local water – don’t drink it.
Review your domestic health insurance policy to determine if you are covered for accidents and illnesses outside of your home country. If you are not, consider purchasing a travel medical insurance policy with the appropriate benefits based on your travel plans.
Know your policy’s emergency travel assistance number.
IMG recommends that any of its members seeking treatment outside of the U.S., utilize its International Provider AccessSM (IPA) database, a network that includes more than 17,000 physicians and facilities worldwide. The network can be accessed via IMG’s customer portal, MyIMGSM, and users can search by physician, facility, specialty or location.
Dr. Hart added that IMG and ACM will continue to monitor the coronavirus situation and the impact it is having on the international community, but in the meantime according to the World Health Organization (WHO), international border closures are not recommended and there are no disease related travel restrictions at this time.

OsoBio appoints Alan P. Heim to Vice President of Human Resources

Albuquerque, NM Oct 3, 2012 – OSO BioPharmaceuticals Manufacturing, LLC, has appointed Alan P. Heim as vice president of human resources.
In his capacity, Heim administers all policies and programs that affect personnel at OsoBio, including issues such as organizational planning; recruitment, hiring and training; employee compensation, performance and benefits; information technology; and labor-related government regulations.
Heim – who has a strong background in organizational leadership and change – brings to OsoBio tremendous experience managing people.
He served for more than 20 years in the U.S. Marine Corps, advancing to the rank of colonel. Among his many tours of duty worldwide included a two-time assignment to the Washington, D.C.-based Joint Operations Staff functioning under then-chairman Gen. Colin Powell.
Upon retiring from the Marines, Heim joined ICN Pharmaceuticals Inc. – now Valeant Pharmaceuticals – as director of organizational planning and development. In 2000, he co-founded Lathian Systems Inc., a software and marketing solutions company for the life-science industry. While there, he helped raise $17 million in venture capital funding, contributed to the company’s profitability and grew it to 40 employees. Most recently, Heim served as vice president of human resources for Directed Electronics.
“OsoBio is growing in large part because of the knowledge, expertise, flexibility and responsiveness of our employees,” said Milton Boyer, president. “Alan has been key in identifying and recruiting people who embrace and exemplify OsoBio’s entrepreneurial culture.”
Heim completed a research fellowship at Harvard University, where he studied and wrote about organizational leadership and change. He earned his master’s degree in human-resource management from Pepperdine University, and was certified as a Senior Professional of Human Resources.