Computer Software Validation

Over the years we have followed and developed approaches to computer systems validations and through on-site experience, practice and following the guidelines set down by ISPE (GAMP), ASTM, EMEA and FDA, we believe we will bring many benefits to your ongoing or new projects. Our philosophy is built on a more IT based structured approaches with key elements being proof of concept, systems design, gap analysis, design review, risk assessment, build to validate (quality by design), implementation with final evaluation testing and continuous improvement.

Simply put, attention to detail in the systems design and a design review phase should happen prior to the systems build. Once the concept is realized and approved the build should begin in a structured manner to allow for validation to commence as the build progresses. Management of the project resources should be allocated to both the build and validation tasks in equal measure.

This approach ultimately results in a quality-designed system which is validate during build. Leveraging ongoing validation during the build and the use of risk-based analysis can also be used to support the validation of a changing system thus reducing timelines.

"Experience dictates that failure to identify the true nature of a system, proper allocation of resource and the realization of the symbiance between the design review, build and validation will ultimately lead to extensions in the project timeline, a reduction in its effectiveness or lowering the quality of the validated system pior to implementation."

Having worked in the laboratory and pharmaceutical sector for a number of years now, we believe we have acquired both the knowledge and experience to speed up and complete any ongoing or new computer software validation related projects. Rather than simply going through the motions of creating documentation for the sake of regulation, our approaches to CSV are more in line with current thinking when referring to GAMP 5 and ASTM2500. Improvements in Quality and efficient Return On Investment should be the two key outputs of any pharmaceutical systems implementation.

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