Expediting Pharmaceutical System Validation with Virtual Machine Technology
We’ve all been there before. Your organization has decided to implement a new clinical system. If patient data touches that system, you know you’ll need to have the entire system validated in a 21 CFR Part 11-compliant way.
The inclusion of a 21 CFR Part 11-compliant validation regimen to a software development project typically adds considerable cost and time, sometimes as much as double the pre-validation estimates. So you go about defining a budget for all the hardware and software required to create three separate environments: Development, Test, and Production, while checking to make sure that the master validation plan (MVP) gives proper attention to each environment. You then finalize the project plan, being careful to make sure all activities required designing, developing, testing, validating, and roll out the system are completed efficiently.
A piece of cake, right? Actually, using traditional methods, it will require a mountain of work. But that might be changing…
Computing technology is rapidly advancing in many directions, with people and processes often struggling to keep pace. Ten years ago, hardly anyone had heard of virtual computing technology, and now it is nearly ubiquitous. Cloud computing, powered by virtualization, has swept through the IT world, causing change in the enterprise, as well as in our personal lives. Conventional concepts and methodologies surrounding computer systems validation have not evolved quite as quickly. We currently find ourselves validating these cloud- or service-based offerings using the same old approach and the same old templates.
On August 15th, the Pharmaceutical Users Software Exchange (PhUSE) an independent, not-for-profit organization run by volunteers to provide a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals, will host a one-day event in Wayne, Pennsylvania. They will bring together experts in software development and the FDA in an effort to explore new and innovative validation methodologies for our industry and to determine what is the appropriate level of risk to allow when validating a new piece of software.
One of many presentations that day is “Expediting the Validation Cycle with Virtual Machine Technology,” by John Leveille, COO at d-Wise Technologies, located in Morrisville, North Carolina. John is a software architect and consultant with more than two decades of experience with SAS and web technologies. He is a former member of SAS Research and Development and continues to maintain close ties to the developers of the SAS product line. At d-Wise, John leads an organization of consultants specializing in informatics solutions for Life Sciences and Healthcare organizations worldwide. He has a strong background in data warehousing, systems integration, and clinical data systems. John’s area of specialty also includes analytic and enterprise systems with multiple industry focus, pharmaceutical software, healthcare payer and provider reporting systems, and scientific data systems.
John’s presentation takes a closer look into the validation cycle and explores ways that virtual machine technology can create efficiencies while improving quality and change control, saving both time and money. As you might imagine, there are many advantages to using virtualization, such as:
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Lower hardware and software costs
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Lower environment maintenance costs and effort
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Simplified project planning and execution
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Simplified project logistics and reduction of dependencies
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More accurate and repeatable stress testing results
And of course, there are also some important issues to consider as well:
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Properly handling software licensing issues in a virtualized environment
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Gaining buy-in from your IT department to accept virtualization
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Getting your QA organization to accept VM technology in a setting requiring validation
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