Business Intelligence Solutions: Automating the Business of Regulatory Compliance
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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