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May 2013
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May 2013
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April 2013 |
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March 2013
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February 2013
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Each year Consumer Goods Technology publishes their top picks for solution and service providers that are poised to make a substantial impact on the consumer goods market with innovative yet necessary tools.
January 2013
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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’ new Audit Execution Package (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.
January 2013 |
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Feeding the Food Supply Chain with Technology
Today, food manufacturers must sell to consumers from different demographics who demand a variety of healthy, high-quality products at low prices. At the same time, they need to adhere to regulations and are already challenged with the high costs of distribution and the need to stay competitive. As a result, manufacturers are turning to technology to address these concerns and ensure quality starts in the supply chain and is reflected behind the labels on store shelves.
October 2012 |
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As device companies continue to focus on enhanced technologies and cost efficiencies in materials and design, there will continue to be wide-ranging impacts for both device manufacturers and regulators to consider as they are tasked with having to find unique enterprise solutions to effectively manage product development and business operations in a highly competitive global market.
October 2012 |
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The high technology and electronics manufacturing industry is complicated, advanced and churns out more new products faster than ever before. There are also more consumers, with greater disposable incomes, spanning the developed and developing world. Consequently, the complex electronics industry demands the introduction of new products at a faster pace to meet customer needs. As a company's global supply chain becomes more complicated, the risks associated with corporate supply chain management comes under greater scrutiny, affecting the top and bottom line of the organization.
September 2012
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Expert Drugmakers looking to reduce product variability through process automation must install connectingcomputerized quality systems at each site to be effective, compliance experts say. July, 2012
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As regulatory oversight in the global pharmaceutical industry increases, more and more companies are turning to technology vendors for guidance on how to help ensure compliance while streamlining critical quality processes
April, 2012
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This article looks at some of the common causes for inconsistency in CAPA processes, and offers several recommendations for how companies can improve their internal systems.
March, 2012
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Read nine simple steps on how to not only determine the scope and size of your EQMS implementation, but also how to convince the necessary stakeholders that quality management is a business imperative essential that drives bottom-line performance and long-term competitive advantages.
November 2011
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The company’s flagship product, TrackWise, has been upgraded with new Web services that can share unstructured content and more efficiently manage user permissions and compliance processes across global operations.
September 2011
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Read more on how food and beverage manufacturers are demonstrating the value of automating critical business processes in an effort to comply with increasing regulatory oversight.
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This report examines recent trends in the Medical Device space and polls industry leaders for their opinions about what’s to come. Read commentary by Sparta Systems on the unintended impacts of globalization on a company’s ability to identify the right design changes for their products.
New Medical Device and Outlook, April, 2011
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Sparta Systems latest byline article on the Food Safety Modernization Act. Read how best-in-class companies are approaching new food safety regulations with centralized, automated tools.
Food Safety Magazine, December 2010
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As the FDA struggles with the changes to the 510(k) process, it may be time for you to review your processes. Read commentary by Sparta Systems on the 510k review process
Medical Design, December, 2010
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A little knowledge is a dangerous thing, particularly when the underinformed individual holds a position of responsibility. To protect patients’ health, regulators require pharmaceutical manufacturers to train employees for their specific jobs on the plant floor. A company’s training-management system affects how quickly employees can get to work and helps a drugmaker demonstrate regulatory compliance. Paper-based training-management systems are well established in the industry, but they can create inefficiencies for some companies. Equipment and Processing report asked Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), about his company’s conversion from a paper-based to an electronic training-management system.
Pharmatech, October, 2010
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The medical device industry has been making headline news recently as the U.S. Food and Drug Administration (FDA) re-examines its regulation and oversight for medical device manufacturers. Regulations haven’t changed dramatically—yet—but the agency has become more conservative, with existing 510(k) processes under tighter scrutiny and an increased emphasis on post-market surveillance.
The shifting regulatory landscape provides medical device manufacturers with an opportunity to cut internal costs and transform quality management processes to more easily meet the regulatory and financial challenges that lie ahead. By controlling what’s within their control, companies more easily can adjust whatever external changes come along down the road.
Medical Product Outsourcing , August 2010
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There's nothing you can do about looming changes to the 510(k) program. But you can take the time to make sure your internal processes are up to snuff.
Mass Device, July 2010
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Incidents such as McNeil Consumer Healthcare’s (New Brunswick, NJ) May 2010 recall of over-the-counter children’s and infants’ liquid products remind patients and drugmakers alike that they cannot take high product quality as a given. Greater process monitoring and control could help reduce manufacturers’ chances of creating out-of-specification dosage forms. Maintaining a constant state of control is essential to staying in the good graces of the US Food and Drug Administration. Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands
Pharmatech, May, 2010
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As the pharmaceutical industry becomes more globalized and companies expand their operations outside the United States, these companies face increasing pressure to comply with differing global regulatory standards that govern operations in diverse geographic locations. The proliferation of global manufacturing processes has led to a rise in internal and external forces that can challenge production standards, related processes, specifications, or even critical documentation. To ensure that product quality is not compromised as operations expand, companies implement controls throughout the organization to ensure that changes are recognized and enforced across boundaries.
Pharmatech, May, 2010
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The discovery of contaminated blood thinner from China in commercial Heparin was a wake-up call for many in the pharmaceutical industry. The 2008 incident, which spanned nine countries and caused at least 21 deaths and 305 allergic reactions in the United States alone, illustrates the complex challenges pharmaceutical companies face in an increasingly competitive, global market.
Quality Magazine, April, 2010
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Quality and IT executives alike face increasing pressure to implement technological solutions that allow the highest level of holistic control and oversight concerning the quality of their operations. This pressure is compounded by the current economic climate in which companies face constant demand to drive cost out of operations by eliminating redundant technology and supporting infrastructure. It’s imperative that the most effective decisions are made when reviewing alternate solution approaches to ensure that both quality and economic efficiencies are realized to the greatest extent possible.
Quality Digest, December, 2009
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While the process of electronic submission of data is a more efficient and traceable means for reporting, it could prove to be a very long and challenging road for the average medical device manufacturer to transition from its current paper-based reporting process to an electronic reporting process.
Life Science Leader, November 2009
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Sparta Systems provides a centralised solution for enhanced quality management for life sciences organisations. European managing director Yaniv Vardi explains the significance of the software for pharmaceutical companies.
CHEManager Magazine, Germany, November, 2009
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An enterprise-wide quality management initiative is required to maintain supplier quality without sacrificing bottom-line objectives.
November, 2009
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The FDA’s Reportable Food Registry electronic portal became operational in early September 2009, requiring food manufacturers, processors, packers and distributors to report potential issues and adverse events electronically within 24 hours.
October, 2009.
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Companies in the life sciences industry are adapting key technologies to fit their very specific business process environments
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With so many moving parts, the ability to repeatedly execute clinical trials with a high level of quality requires a comprehensive and adaptable Clinical Quality Management (CQM) program.
August 2009
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With reports of supply quality failures making front-page headlines almost daily, business-crippling quality issues are proving disastrous for global life sciences companies and their stakeholders. For this reason, quality management has quickly moved to the forefront of priorities for both life sciences companies and their stakeholders.
March 2009, Page 30
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Drug companies lose upwards of $600,000 - $1M of revenue for every day their drug is not available in the market. Typically these figures are drawn to represent the need for speedy clinical development; however, in this article we will talk about the enormous financial detriment of having a drug pulled from the market – even temporarily – by a regulatory agency due to a host of possible reasons.
February 2009
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Corrective and preventive action management is vital to an organization’s quality management initiatives. It ensures that issues that appear unexpectedly in the manufacturing process can be addressed quickly and efficiently, with procedures implemented that can make certain these issues do not repeat themselves.
February 2009
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“…..Fifteen-year-old Sparta Systems' TrackWise application, for example, keeps track of errors and other deviations reported through MES systems or other sources, such as incoming inspection. The system uses workflow to route events to the proper individuals for resolution, and can be used to perform root cause analysis into what's behind the quality problem.
February 2009
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Many manufacturers have gone or are going through changes as the challenging economic times continue. Companies are consolidating—buying out competitors through mergers and acquisitions, thinning their workforces through layoffs or merging locations in an effort to save money—all while trying to maintain the highest level of quality.
January 2009
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