Kalleid Testing & Validation

Importance of Testing & Validation

The FDA mandates the use of risk-based computer system validation (CSV) processes based on applicable regulations and guidance (GAMP®5) for systems utilized in GxP environments in order to confirm systems are fit for intended use. Whether your computer system operates in a GxP or non-GxP environment, an informed testing strategy is essential to ensure you can trust your data and mitigate any performance issues.

Testing and validation activities are important when configuring a new system or making changes (upgrades, patches, extensions, etc.) to a system already in use. As scientific software is typically changed frequently to satisfy changing regulatory and business requirements, life science companies need to perform testing and validation activities on an ongoing basis to reduce compliance risk, maintain data integrity, and ensure product safety and efficacy.

It is also important to recognize that FDA-regulated laboratories are required to conduct risk-based validation activities on any equipment and/or instruments that are linked to the system. In addition, FDA regulations require life science organizations to document staff compliance with standard operating procedures (SOPs) and manuals when operating the system.

Validation Documentation

Our professionals follow a proven, best practice methodology when conducting testing and validation activities for your organization and will provide you with the following validation documentation:

• System assessment and inventory
• User and functional requirement specifications
• Risk assessments and Validation Plan
• Installation qualification (IQ) scripts and results
• Operational qualification (OQ) scripts and results
• Performance qualification (PQ) scripts and results
• Final Validation Report
• System release documentation
• Standard operating procedures (SOPs)

A thorough workflow and business analysis is a critical part of the validation process. A good business analysis will produce clear and precise user and functional requirements that are tailored to the unique demands of your operating environment, and are written in sufficient detail to effectively guide the validation process. Without a clear set of requirements, even the best validation protocols will not be able to verify that the system is functioning as intended.

As regulatory action by the FDA the failure to perform adequate validation activities can be legally and financially devastating to an organization, life science organizations need their CSV processes done right in order to reduce business liability issues related to compliance risk and data integrity concerns. Kalleid has the ability to leverage a network of world-renown data structure experts with the specific knowledge to identify and execute a risk-based approach to testing and securing data integrity in any application.