The requirement to validate software is an ever increasing one and is spreading to activities that support the manufacture of Pharmaceutical, Medical Device and Biotech industries.  The US FDA (Food and Drug Administration) recently re-issued its guidance on Computerized Systems Used in Clinical Investigations (May 2007) which reemphasized the requirement for software validation, and is a good example of where the application of ItemTracker would require validation.

Using this approach, we can tailor the validation effort to the needs of the customer.  This can range from simple advice and guidance that allows the user to perform their own configuration of the system, through to generating a full suite of validation documents as detailed in the model above.

This complete approach is often the quickest way to implement the software. It combines our specialist skills and experience along with users’ knowledge of how they want the system to meet their requirements.