Using a risk-based approach, we find the most effective and cost-efficient validation method for your project, compliant with your existing processes and current regulatory requirements.
We begin by assessing your system based on:
Specifications are a primary component to any software solution--they are the foundation of system design, intended business use, and testing. Performance Validation professionals understand the need for accurate, complete, and testable requirements that can be scaled based on system risk, complexity, and criticality.
Testing plays a critical role in a validation. Appropriate design and execution of testing facilitates accurate system installation verification, system functionality qualification, and assurance that the system meets its intended use per system specifications (e.g. User Requirements). Performance Validation develops and executes a right-size approach for testing protocols. We leverage supplier/vendor testing and implement risk-based methods that will optimize and align with your validation project budget and schedule.
Validation reports provide internal/external auditors and stakeholders valuable information on validation results.
Performance Validation provides structure and guidance for maintaining a system’s validated state. This is necessary when implementing system updates, bug fixes, enhancements, and patches.
We have extensive experience advising clients and training their staff on computer system validation initiatives. We offer customized instruction covering best practices and industry standards that will help your organization develop and implement a compliant computer system validation program.
Our CSV team specializes in assessing unvalidated “legacy” systems that may require remediation. A Performance Validation audit can help determine the best way to bring your system into compliance.
Have Questions? Set up a no-obligation initial consultation and learn how Performance Validation can design a CSV solution for you. Contact us today.
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