Improve Your Computer System Validation Process
You know that your approach to software validation could be more efficient or more compliant, but you don’t know where to begin.
If you have not yet implemented risk based validation methodologies, you might be performing too many validation activities for some systems, and not enough for others.
Let our experienced computer system validation consultants help identify process improvements and incorporate risk-based practices into your methodology.
Get help from our ExpertsOur team quickly simplified the process, removing unnecessary tasks for low-risk systems
Customer Success Story
A CRO was struggling with a computer system validation methodology that had grown in complexity over the years. Consequently projects were taking longer and audit observations were increasing as everyone struggled with the complicated process.
Our team quickly simplified the process by implementing risk-based quality assurance practices to remove unnecessary tasks for low-risk systems and utilizing LEAN techniques to remove non-value added steps. We also helped the CRO select new technologies to improve the efficiency of producing and approving validation deliverables.
We can help you implement a compliant and cost-effective software validation approach.
Our team will:
- Identify the FDA and international regulations and guidelines that apply to your business. Examples include 21 CFR Part 11, Annex 11, FDA’s General Principles of Software Validation
- Evaluate and assess your current validation procedures and practices vs. regulations 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 new procedures
- Deliver ongoing support throughout your first validation project with the revised procedures
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