How can the PAT700 help support 21CFR Part 11 for TOC records?

The ANATEL 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.

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NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES. PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS The listed regulatory status for products correspond to one of the below: IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use." ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagent. Analytical and performance characteristics are not established." CE-IVD, CE: Products intended for in vitro diagnostic use and conforming to the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. (Note: Devices may be CE marked to other directives.) RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures." LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only." No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.