Validation Process Improvement
If you know that your approach to software validation could be more efficient or more compliant, our expert consultants can help you identify process improvements and incorporate risk-based practices into your methodology.
As with any GxP process, Validation SOPs need to be periodically reviewed and updated to current standards. In the fast-moving world of technology, regulations change frequently, and industry norms change even faster.
If your organization has not yet implemented computer software assurance (CSA) and other risk-based validation methodologies, you might be performing too many validation activities for some systems, and not enough for others. Today’s approaches for validating custom software vs. SaaS applications is vastly different.
Or, if you suspect that your approach to software validation could be more efficient, we can help you identify process improvements and incorporate them into your methodology.
Our Approach to Implementing a Compliant CSV & CSA Program
We apply the following approach to implementing a computer system validation program that complies with FDA regulations, EU regulatory expectations, and industry best practices.
- Identify the FDA, EMA, MHRA and other regulations and guidelines that apply to your business. Examples include 21 CFR Part 11, Annex 11, FDA General Principles of Software Validation, FDA Computer Software Assurance for Production and Quality Systems
- Evaluate and assess your current validation procedures and practices vs. regulations, guidelines, and industry best practices
- Adjust your current procedures to close compliance gaps, implement risk-based methodologies, and address inefficiencies
- Educate your staff in the use of the revised procedures
- Deliver ongoing support throughout your first validation project with the revised procedures
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Improving Your Validation Processes Delivers Key Results
Our specialists deliver results that include:
- Reduction in inspection risk because procedures are aligned with current regulations and industry best practices
- Validation methodologies and approaches appropriate for system risk levels, i.e., not too much, but not too little
- Quicker validation project timelines, achieved by removing unnecessary steps.