Hamilton, NJ Nov 28, 2012 – Sparta Systems, Inc., the market leader in enterprise quality and management solutions, today announced the grand opening of its new global headquarters in Hamilton, N.J. Sparta will celebrate the official opening with state and local officials, business partners and representatives from the Company’s Fortune 500 customers, at an all day event on Wednesday, November 28. The event will showcase the new facility and feature customer workshops on industry trends and new products.
Originally based in Holmdel, N.J., Sparta has called New Jersey home for the past 18 years. Proving its value to the region, Sparta recently received Business Employment Initiative and Business Retention and Relocation Assistance grants from the New Jersey Economic Development Authority (EDA), totaling more than $2 million, to add and retain jobs in the Garden State.
“From competitive business incentives to significant tax reforms, our ongoing efforts to make New Jersey a home for job creation and economic growth are producing the kind of tangible results that lead pioneering, world-class companies like Sparta Systems to remain and grow in our state,” said EDA CEO Michele Brown. “The EDA is happy to have supported this innovative company in opening its new headquarters and further expanding New Jersey’s vibrant technology sector.”
Eileen Martinson, CEO of Sparta Systems, further commented, “As companies grow and expand, it is their responsibility to help grow the local economy as well. At Sparta, we felt it important to maintain our New Jersey heritage and continue on our already established growth path in the region. The State’s unwavering support made our decision to move to Hamilton an easy one, and we look forward to what lies ahead in our company expansion.”
Sparta has a strong presence in the region having recently been named the 2012 Software Company of the Year by the New Jersey Technology Council (NJTC). The award recognizes Sparta as a leader among New Jersey technology vendors based on its industry impact, growth rate and success in the marketplace. With an extensive install base in the pharmaceutical, medical device, electronics manufacturing and consumer packaged goods industries, the new headquarters and state of the art training facility will help Sparta reach more customers and enable them to safely and efficiently deliver products and services to market.
Category: news
The Vascular Quality Initiative® Reaches a New Milestone with More than 200 Participating Centers
West Lebanon, NH Nov 28, 2012 – The Vascular Quality Initiative® (VQI), designed to improve the quality of vascular healthcare has reached a significant milestone by surpassing 200 participating centers. The VQI® is a joint partnership between M2S and the Society for Vascular Surgery® (SVS) Patient Safety Organization. Reaching this mark positions the VQI® as the fastest growing quality improvement database in North America since launching in February 2011
“SVS and its members strive for the highest quality in treating vascular patients,” said Peter Gloviczki, SVS President. “VQI has experienced fast growth and continued penetration in the vascular health field because it offers the tools and mechanisms to accurately measure important quality parameters and compare them to benchmarks. Outcomes are benchmarked with peers, regionally, and then applied locally to support internal quality assurance and quality improvement projects.”
In just over a year and a half since inception, the VQI has grown exponentially in not only its number of participating centers, but also in the number of physicians collecting and entering procedural and outcome data. The database accumulates an average 3,500 procedures each month, further enhancing the value of benchmarking outcomes among providers and influencing quality improvement projects and quality research.
The regional quality groups of the VQI are fundamental for driving quality initiatives at the local level that reduce length of stay, readmissions, and complications. They also are important in fostering initiatives that can lead to best practice recommendations. Recently, the Quality Committee of the VQI, which is composed of physician representatives from each of the established regional groups, analyzed in-hospital surgical site infection after infra-inguinal bypass, finding significant variation in risk-adjusted rates across participating centers. Based on the findings of this project, the committee plans to prepare a scientific manuscript and quality recommendation.
Sparta Systems Bundles Offering to Simplify Audit Management
Hamilton, NJ Nov 13, 2012 –
The Audit Execution Package Suite Accelerates Time to Value With Streamlined Services and Training
Sparta Systems, Inc., the market leader in enterprise quality and compliance management solutions, announced the availability of its Audit Execution Package (AEP) Suite, a bundled offering comprised of the TrackWise AEP software and tailored services and training. The suite includes support from an implementation consultant and an audit management subject matter expert to provide for a rapid implementation, accelerated user adoption and a high level of confidence in adhering to relevant industry standards and regulations.
The process of conducting audits is time consuming and expensive, frequently requiring volumes of documentation. If not automated, the process and resulting data can be riddled with problematic and costly inconsistencies and inefficiencies. Sparta Systems’ AEP Suite enables organizations across multiple industries to automate audit processes, providing tangible increases in productivity and a level of visibility and transparency that is simply not possible using manual legacy systems and processes.
“The necessity to hold internal departments and external partners to the highest level of quality continues to pose cost containment challenges in life sciences, consumer products, and electronics manufacturing industries,” said Mike Jovanis, Vice President, Product Management and Strategy at Sparta Systems. “The AEP Suite illustrates our continuing commitment to innovate how we deliver product to accelerate time to value while reducing the long term cost.”
The AEP Suite offers the ability to create tailored templates to streamline auditing processes and provides organizations sophisticated reporting to analyze results across audit programs. This solution does not require auditors to be “connected” and allows them to “check-out” an audit and conduct all relevant work while in the field. These capabilities are in addition to the ability to manage the end-to-end audit management lifecycle within TrackWise, as one element of a holistic quality management system.
Paragon Medical Inducted into Kosciusko County Entrepreneur and Innovation Hall of Fame
Pierceton, IN Nov 9, 2011 – Pierceton based Paragon Medical and its Founder and CEO Tobias Buck were inducted into the Kosciusko County Entrepreneur and Innovation Hall of Fame on Thursday, November 8th in Warsaw, Indiana. As a member of only the second Hall of Fame class, Paragon was among six businesses chosen from orthopaedics, agriculture, recreational-boat, manufacturing and retail industries.
The award honors both the company as a whole and the key entrepreneur behind its success. According to the Kosciusko Economic Development Corporation (KEDCo), who sponsors the award, it was created to not only recognize entrepreneurial organizations in the community but also to reinforce the pride of employees and citizens in the success of the local business environment and position Kosciusko County for a growing and vital economic future.
Paragon Medical began as a vision in 1991 to become the total delivery solution to the worldwide market, providing custom surgical instruments and implantable components as well as polymer, metal and hybrid case and tray delivery systems, with all the design and manufacturing support capabilities integrated into one campus.
With only a little over 20 years in business, Paragon has become a leading tier 1, turnkey supplier of world-class solutions to the medical device marketplace. The company has grown from a start-up business with only a handful of employees to a global company approaching 1,000 employees and multiple manufacturing locations in three countries.
“Paragon Medical has a culture that reflects Toby’s personality and beliefs”, commented Sheryl Conley, OrthoWorx CEO in her introductory comments for Buck’s award at the induction ceremony. “That it’s about quality and relationships, working together for a common good. Paragon has brought world-class technology in design, manufacturing and quality to their business. But anyone who knows Toby will tell you Paragon is a people business, because Toby is about making, building and keeping relationships that stand the test of time.”
Daniel Owens, Paragon Medical’s Worldwide Director of New Product Introduction and Engineering, who has also been with the company since the beginning, accepted the award on behalf of the company. Tobias Buck, Paragon’s Chairman and CEO accepted the award on his own behalf.
OsoBio President Milton Boyer Appointed to DCAT Executive Committee
Albuquerque, NM Nov 8, 2012 – Milton Boyer, president of OsoBio, has been appointed to the executive committee of the Drug, Chemical and Associated Technologies Association (DCAT).
Boyer – whose term began Nov. 1 – will represent the contract formulation, fill, finish, and contract packaging industry as segment vice president. Boyer joined the DCAT board of directors last year.
Founded in 1891, DCAT is the premier business development association whose membership consists of companies that manufacture, distribute or provide services to the pharmaceutical, chemical and related industries. More than 300 corporate members belong to DCAT.
“DCAT is one of the most unique trade organizations in our industry. Because it is truly member-run, each individual has an opportunity to make a distinctive impact, and new initiatives continue to increase the organization’s value proposition,” Boyer said. “I am honored to be selected for this position by my industry peers and look forward to serving in my new role.”
In addition to his board membership at DCAT, Boyer is a member of the International Society of Pharmaceutical Engineers (ISPE) and the American Association of Pharmaceutical Scientists (AAPS).
OSO BioPharmaceuticals Manufacturing LLC – OsoBio for short – is a contract manufacturing organization (CMO) that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. The company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.
In the history of its Albuquerque, N.M., facility, OsoBio has manufactured more than 250 distinct commercial presentations in every major therapeutic category. The U.S. Drug Enforcement Administration (DEA) has granted OsoBio registrations for Schedule II through V controlled substances.
Oasis Outsourcing CEO Mark Perlberg Elected Chairman of Employer Services Assurance Corporation
West Palm Beach, FL Nov 6, 2012 – Mark Perlberg, President and CEO of Oasis Outsourcing, has been elected Chairman of the Employer Services Assurance Corporation (ESAC) and will lead the association’s board of directors in administering its accreditation program for the $81 billion professional employer organization (PEO) industry.
“Mark’s years of leadership experience and his demonstrated expertise in strategic development provide an ideal combination of skills and experience to lead ESAC’s board of directors,” said Jane McCoggins, ESAC COO. “His background is a perfect foundation to help enhance ESAC’s work in providing financial assurance and independent verification of a PEO’s compliance with financial, ethical and operational standards for business owners seeking to outsource human resource functions to a PEO.”
“I am honored to be involved in ESAC, which is such an important organization to the PEO industry,” said Perlberg. “As chairman, I hope to work collectively to streamline the ESAC accreditation process and support the needs of PEOs throughout the country— while maintaining the organization’s integrity, mission and values.”
ESAC accredited PEOs, providing human resources management, employee benefits, payroll and workers’ compensation, serve businesses representing over $40 billion in annual employee wages.
Oasis Outsourcing, like all ESAC accredited PEOs, undergoes rigorous examination by outside experts, who conduct background investigations and review business functions, including employment and service practices, financial and accounting standards, and applicable state and federal regulations. As part of its accreditation process, ESAC also monitors each PEO’s quarterly internal and annual audited financial statements as well as quarterly verifications by an independent CPA of the PEO’s appropriate payment of taxes, benefit contributions and insurance premiums.
“The value of ESAC accreditation is easy for business owners to understand,” said Perlberg. The primary benefit is the verification of each accredited PEO’s adherence to important industry standards. As an additional value, ESAC’s PEO Client Assurance Program, which is comparable to the FDIC insurance program for the banking industry, provides for financial reimbursement to clients, worksite employees, vendors and taxing authorities in the event the accredited PEO does not perform its service obligations for the payment of wages, payroll taxes, contributions to employee retirement plans, workers’ compensation premiums and group life and health insurance premiums. This assurance is backed by $11 million in surety bonds held in Trust through the ESAC Client Assurance Program.
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.
OsoBio promotes Bob Cashman to Vice President of Business Development
Albuquerque, NM Sep 18, 2012 – Robert “Bob” Cashman has been promoted to vice president of business development at OSO BioPharmaceuticals Manufacturing, LLC.
In his new role, Cashman is responsible for developing and executing strategies to expand the company’s injectable pharmaceutical contract manufacturing business. He also will oversee existing and potential customer relationships, manage pricing structures, and direct strategic corporate alliances.
Cashman, who joined OsoBio in 2009, previously served as director of new business development for the company’s East Coast market. He steps into a position vacated by Milton Boyer, who was appointed president of OsoBio in February.
“Bob has consistently demonstrated a keen ability to foster existing and new client opportunities for OsoBio,” Boyer said. “As OsoBio continues to successfully grow as a CMO renowned for world-class customer care, project management and regulatory compliance, I know Bob will help us achieve the goals we’ve set for ourselves.”
With more than 20 years of experience in contract pharmaceutical and biotechnology manufacturing, Cashman is a board member of the Philadelphia Drug Exchange, the oldest continually active trade organization in the United States. A member of the Parenteral Drug Association, he also heads the scholarship committee for the Drug, Chemical and Associated Technologies Association (DCAT). Cashman holds a bachelor’s degree in business administration from Villanova University.