Blogs and Apps that Bring Solutions

Suppliers and Service Providers: Contact Julie Vetalice to discuss coverage of your currently active blog or app for smartphones and tablet devices: This email address is being protected from spambots. You need JavaScript enabled to view it. or 440.543.2101.

Business Intelligence Solutions: Automating the Business of Regulatory Compliance

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When you are ready for guidance and solutions on matters of regulatory compliance, validation and IT services, Business Intelligence Solutions (BIS) will help you capitalize on your investments in people, processes and technology. The BIS web site provides access to an enormous number of tools to help readers educate themselves, ask questions, discover new conferences and think their way through to solutions. Readers will find blog articles, white papers, PowerPoint presentations, case studies, videos and more.

Established in 1998, the BIS Blog has steadily informed readers on topics such as:

  • Crucial Requirements for a Successful Validation Project: The FDA's General Principles of Software Validation (GPSV), emphasizing how crucial requirements are to successful validation, recognizes the requirements for a successful validation project are difficult, if not impossible, to create accurately and to an adequate level of detail in one pass.
  • Validation of Excel Spreadsheets: Spreadsheets are very useful in calculating, graphing, and manipulating data. The use of validated spreadsheet saves review time by ensuring that the same calculations are done each time the spreadsheet is used.
  • Dirty Little Secrets of Contract Manufacturers: For many contract manufacturers, the ability to meet FDA concerns, in the form of a warning letter for example, will be crucial for their long term survival. Often this is not a result of a failure to take a critical, honest look at how their quality systems meet FDA regulations but the new zero tolerance policy of FDA enforcement.
  • Are You Keeping Up with Opportunity or Falling Behind? FDA regulated companies that are falling behind are maintaining paper-based systems and one reason for the lag is quite evident. Quality systems that include paper-based or hybrid document control processes put companies at a competitive disadvantage.

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GHX: The Healthcare Hub

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The Healthcare Hub looks at major issues impacting the healthcare industry, with insights into how greater collaboration and visibility across the supply chain can improve both clinical and financial performance. Content on the site draws upon the perspectives of manufacturers, distributors, hospitals, clinicians and group purchasing organizations working with GHX ( in North America and Europe, as well as leaders from the government, analyst, academic and payer communities. The Healthcare Hub features blog posts, as well as links to video and pod casts, the GHX Industry Perspective newsletter and other blogs we consider worth following. Topics include:

  • The role of cloud computing in healthcare
  • Why Wall Street should reconsider how it values medical device companies
  • How medical device manufacturers and major IDNs are working together to improve the implantable device supply chain
  • What manufacturers need to do now to prepare for the pending unique device identification (UDI) rule
  • A physician's perspective on the healthcare supply chain
  • The Healthcare Hub focuses on the supply chain because – while often ignored in discussions of healthcare reform - it can help lower operational costs while providing critical insights into the role suppliers contribute to better quality, both of which are key components to delivering greater value in healthcare. The supply chain can also provide a unifying element that can better align the various parties that source, sell, deliver, use, and pay for life-saving medical and surgical products.

    With implantable devices often accounting for more than 50 percent of the cost of some procedures, and regulations such as the UDI rule and bundled payments on the horizon, The Healthcare Hub plans increased coverage of issues impacting the orthopaedic supply chain and how a more standardized approach can provide value to clinicians, hospitals and medical device manufacturers and distributors.

    We welcome guest blogs, as well as comments on current content and suggestions for future topics to cover. Come visit us, and share your perspectives and commentary.

    Visit the Healthcare Hub Blog.