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:

• GxP Requirements and criticality
• Software category (based on ISPE GAMP® 5)
• Supplier assessments and/or audits System scope complexity

Services Offered:

• Enterprise validation master plans and supporting procedures
• Validation management (with detailed reporting around expenses, project status, milestone management and tracking)
• Validation project plan development and implementation
• Regulatory gap analysis and remediation (e.g., 21 CFR Part 11, cGMP, GLP, data integrity)
• Supplier/vendor audits
• System risk-level assessments
• Standard Operating Procedure authoring/consultation
• Vendor documentation leveraging (to reduce validation burden)

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. Services Offered:

• User requirement specification
• Functional specification
• Design specification
• Requirements traceability matrices

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.

Services Offered:

• Infrastructure verification
• Installation Qualification – verification of the application installation and component configurations
• Operational Qualification (OQ) – Functional testing of the application to demonstrate software function per design requirements (depending on the GAMP^® 5 category, this testing may be fulfilled through vendor audit or full functional testing)
• Performance Qualification (PQ) – Use-case testing (to verify that software meets user requirements and intended software use)
• User Acceptance Testing (UAT)
• Onsite or remote test execution

Validation reports provide internal/external auditors and stakeholders valuable information on validation results.

Services Offered:

• IQ/ /OQ/PQ testing summary reports
• Validation Summary Reports, Final Report

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.

Services Offered:

• Change control planning
• Documentation updates
• Testing (e.g., stress and regression)
• Data migration verification
• Periodic reviews
• Data integrity assessment and remediation

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.