This department not only plays a role in ensuring that data integrity is the highest of priorities, it also ensures that proper change control and configuration management are in place for all systems-based functions. The Validation Team works closely with each operational department to ensure that proper requirements are gathered and are in compliance with our comprehensive policies and procedures. Activities of the department include, but are not limited to, the following:

• Development and execution of validation
• Plans and test scripts for new clinical systems
• Reviews to ensure appropriate configuration management is in place
• Detection and reporting of any errors
• Development of summary documentation for validation projects which is made available to clients during on-site visits
• Testing for change requests to existing clinical systems

In addition to performing testing of clinical systems, the IT Validation Team is involved in performing IT audits for regulatory compliance (i.e. 21 CFR part 11) for internal systems, potential new systems and affiliate laboratories.