Computer System Validation Auditing Services

A Tailored Approach, Utilizing Our Deep Understanding of CSV Systems and Their Associated GxP Processes

With the increasing reliance on computer systems in the pharmaceutical, biologics, and medical device industries, validation of these systems according to GxP requirements continues to be a growing focus for regulatory agencies to ensure patient safety. With the adoption of new technologies in automation, seemingly every day, this can quickly become a costly venture if the validation strategy is not implemented in a cost-effective, right-sized approach.

ProPharma Group offers a particular set of computer systems validation skills to tailor the validation strategy to your compliance requirements, needs, and processes. By tapping into our vast experience in current regulatory and industry best practice expectations for a wide variety of systems, we build efficiencies as our teams quickly and critically analyze and provide practical, value-added evaluations and recommendations against those requirements. ProPharma Group helps you identify compliance gaps in your systems, in all stages of the lifecycle of your computerized system, and takes the extra step to provide value planning in every engagement, allowing for consistent and reusable outcome efficiencies.