How can the PAT700 help support 21CFR Part 11 for TOC records?
The PAT700 has eliminated manual calculations and manual data-entry, two of the more common causes of data-integrity problems.
The PAT700 has automated SOPs for all Calibration and System Suitability pre-programmed in, taking the user step-by-step through each procedure. In addition, the Calibration and System Suitability certified standards have an RFID tag containing their certified value and expiry date. The PAT700 reads the RFID tag on each bottle, thus eliminating the need to manually enter the data, and warns the user if the standards have been inserted in the wrong order, or if the standards have expired. The automated SOPs carry out the required procedure and then automatically calculate a Pass/Fail result, then providing a report print-out tying all the pieces of information together.