Category Archives: Pharmaceutical & Biotech

Thoughts from the Supplier Quality Management Congress

Bethesda, MD was abuzz this past week as the FDANews.com hosted the 2nd Annual Supplier Quality Management Congress held at the Bethesda North Marriott Hotel & Conference Center. At the event, supplier quality personnel from both pharmaceutical and medical device organizations came together to exchange ideas and information about the ever changing supply chain.

Day one started with a keynote address from two well respected FDA representatives, Dr. Carmelo Rosa who shared some interesting statistics about warning letters for the pharmaceutical space. Read full article

TrackWise SelectStart: Small- to Medium-Sized Business See Large Benefits in Quality Management

Today we announced the launch of TrackWise SelectStart, a packaged solution offering for small-to-medium businesses (SMBs) who are facing the challenges of responding to increasing regulatory changes and dwindling budgets. Unlike the large companies they often resemble, SMBs must answer to consumer’s safety concerns and government agency requirements without similar financial resources.

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Making the Move from Paper to Electronic Quality Management

When and how to implement an electronic quality management solution are persistent questions for small and medium-size life sciences companies. The recent webcast hosted by Pharmaceutical Technology and sponsored by Sparta Systems called, “What Early Stage Companies Need to Know About Quality Management: Lessons Learned from Industry Leaders” provided insight to help companies planning to move from paper to electronic processes . Tim Mohn of Sparta Systems started the program by presenting the “big picture” on the topic of QMS, including triggers for adoption and key benefits. Tim’s poll of the audience showed over 76% are still using at least some paper-based processes, and that the biggest obstacles to implementing a QMS for over 55% of respondents are proving ROI and getting employee resources to support the project.

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Mitigate Risk with EQMS

No matter your business, risk is a factor. You need to control it. You need a single, enterprise-wide quality management software solution, one that doesn’t burden your budgets or the applications you’re already using.

TrackWise EQMS (Enterprise Quality Management Solution) is the answer. It tackles all issues, actions, and changes enterprise-wide, making your quality control centralized and efficient. Seamlessly integrating with the systems you already have, TrackWise QMS effortlessly coexists with ERP, LIMS, MES, CRM and other SOA environments. It enables you to cover the key quality, compliance and regulatory needs, which means you increase your quality and ROI.

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BROUGHT TO YOU BY SPARTA SYSTEMS

Since 1994, Sparta Systems, Inc. has advocated the need for accountability and control of work-flow processes, along with clarity and transparency. Our experience in highly regulated industries is unmatched, as is our commitment to providing visibility of mission-critical attributes from a centralized system through a global process.

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ashley-watkins-2Ashley Watkins Industry Solution Associate

Ashley is an Industry Solution Associate in Sparta Systems’ Product Management and Strategy group. Ashley works with the Industry Solution team to develop product, solution, and marketing strategy for Sparta’s targeted markets. She is responsible for building business cases and market analysis, developing messaging and positioning for products and solutions, and generating content to support marketing and sales activities. Ashley received her bachelor’s degree in biology and music from Boston College and her master’s degree in biotechnology from Columbia University.

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