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 Computerised Systems Used in Clinical Investigations (May 2007) which reemphasised the requirement for software validation, and is a good example of where the application of ItemTracker would require validation.
There are many models that can be used when validating software. For ItemTracker we have chosen GAMP (Good Automated Manufacturing Practice) as the preferred model. A simplified version of the model is shown. For more information see the Regulations page.
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.
Contact us for more details.