Validation Process Improvement
If your software validation approach feels inefficient or outdated, our expert consultants can help modernize your program by introducing risk-based practices and aligning with the latest CSV and CSA methodologies.
Organizations that have not yet implemented Computer Software Assurance (CSA) often over-validate low-risk systems while under-validating critical ones. Today’s best practices distinguish sharply between custom-built software and SaaS applications—and your processes need to reflect that.
Like all GxP processes, Validation SOPs require periodic review and updates. In a fast-moving regulatory and technology environment, falling behind increases compliance risk and slows delivery.
Our Approach to Process Improvement
We ensure your validation program is both compliant and cost-effective by:
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Identifying the FDA, EMA, MHRA, and other regulations that apply to your systems (e.g., 21 CFR Part 11, Annex 11, FDA CSV and CSA guidance).
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Assessing your current validation procedures against regulatory expectations and industry best practices.
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Updating SOPs to close compliance gaps, embed risk-based methods, and streamline inefficiencies.
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Training staff to apply the revised procedures effectively.
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Providing ongoing support during your first validation project under the new framework.
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Offering on-demand advisory services via retainer if you only need targeted guidance.
Improving Your Validation Processes Delivers Key Results
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Reduced inspection risk by ensuring alignment with current regulations and industry norms.
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Right-sized validation effort—not too much for low-risk systems, not too little for high-risk ones.
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Accelerated project timelines by eliminating unnecessary steps and focusing on value-added activities.