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Compliance and Validation Research Study Complete!

March 21, 2014 by
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We recently conducted compliance and validation research that focused on understanding pain points, trends and purchasing behaviours specific to the pharmaceutical industry in North America. The purpose of the research was to understand market opportunities related to the use of automated computer system validation software. To meet the objectives of the study, one-on-one interviews were conducted with executives within the industry. The interviewees comprised IT Directors, Quality Assurance & Compliance Directors and other executives knowledgeable about compliance and validation. The interviewees included executives from large pharmaceutical companies such as Merck, Novartis, Sanofi Pasteur and Bristol Myers-Squibb as well as mid and small-sized companies across the pharmaceutical industry value chain, from contract research organizations to contract marketing organizations. Contact us for an exclusive opportunity to  review the compliance and validation research and gain insights and learnings that will help drive successful validation strategy and planning for your business.


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Computer System Validation – How Much To Validate?

March 10, 2014 by
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How much to validate is the biggest challenge facing validation professionals and their organizations.  Deciding how much to validate is a delicate balance between satisfying compliance requirements and the time it takes to implement critical technologies. Why is this a challenge for organizations?  When you consider compliance requirements you must first consider cost.  Validation is an overhead cost, not a profit driving business activity.   As a result the decision of how much to validate becomes an important question that impacts both time and money. The second point to consider is the company’s interpretation of FDA or other regulatory agency guidelines.   A lack of understanding of these guidelines often results in 2 scenarios: 1) Over documentation, or too much validation, which increases the time it takes to enable and implement critical technologies. This may result in a delay to market and negative impact on revenues. 2) Not enough documentation, or lack of validation, which presents the risk of failing regulatory audits. This may result in recalls or significant fines, which can also negatively impact revenues. The final point to consider is lack of resources.  In many organizations, being able to answer the question of how much to validate depends on the professionals themselves.  Not having enough committed resources negatively impacts cost and timing. For many professionals, achieving the delicate balance between…


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