Validation Services

For Software Validations, the Validation Services Team is able to conduct a fully risk managed and documented validation project with minimal impact to your organization’s resources. IQS is able to bring its own expert resources, focused on accomplishing the task of validation and providing all the necessary outputs and documentation. We can also work with your own internal experts, providing the level of support that you need to accomplish the validation, from full turnkey to a minimally assisted validation exercises.

We employ a risk managed approach to validation that analyzes the software, process, or system, to identify and rate each potential risk in order to design the optimal validation solution. This approach can be applied to almost any validation requirement and provides a justification for focused validation testing that verifies critical functionality and minimizes the time spent on elements that present little to no risk. 

Additional Services that we offer include:

• Pre-Validation Planning to determine what needs to be validated and ensure that all elements of a validation are considered within the overall project plan of the validation or software implementation.
• 21 CFR Part 11 Compliance for electronic signatures and electronic records.
• IT infrastructure, including hardware as well as operating and management systems.
• Enterprise software validation for business operations including ERP, QMS and EDM systems.
• Production software including MES and other Level 3 systems.
• Laboratory software for LIMS, chromatography systems and instrumentation.
• Automated process controls including PLC, DCS and HMI based systems.