EtQ recognizes the enormous task of FDA Compliance, and has optional services to help regulated companies quickly and confidently validate their EtQ environment. EtQ Validation Services provides three optional choices to assist the FDA regulated customer to meet the FDA's validation requirements.
Read about eValidation
To leverage the investment of an organization's internal validation resources, EtQ provides sample documentation and classroom training on the documentation to assist the customer with their validation. The documents and training dovetail with EtQ's installation service and administration training service, providing the customer with a clear path to follow in validating their implementation of EtQ's FDA Compliance Software.
For those organizations without validation resources, EtQ will provide the documentation, classroom training on the documentation, configuration services, will execute the test scripts, and draft the final reports necessary to document the completed validation.
For companies regulated by the Food and Drug Administration (FDA), systems validation is a necessary requirement to ensure a secure environment. The process of validating an enterprise system involves running test scripts at the installation level, the process level and the operational level (called IQ, PQ, and OQ, respectively). These scripts are often long and time consuming, and can take months, if not a whole year to compile and run. Recognizing this incredible task of validation, EtQ has released the eValidator utility, which is designed to automate the PQ process. The eValidator is a comprehensive set of commands that, when executed, will run the test scripts automatically, and generate a full report of the results of this script. The ramifications of the eValidator are staggering. Streamlining the validation process can have a tremendous effect on both a company's implementation time and personnel resources. Using eValidator to automate the validation process will cut a company's validation time by as much as 400% - a 4 day validation project can be done in less than a day using EtQ's eValidator. Furthermore, the eValidator can be run by a single employee, and can eliminate the extensive resources needed to dedicate to a typical validation project. Finally, eValidator is able to compile a comprehensive report library of all tests and scripts run on the system. When audited by the FDA or other governing body, the validation reports are immediately available for review.