For SMARTDAC+ GX/GP series, which advanced security function (/AS) models apply to which category classifications in the "Computerized system adequacy management guidelines at pharmaceutical and quasi-drug manufacturing and sales companies?"

Category classifications differ depending on the suffix codes.
If neither the MATH nor custom display are added, it's category 3.
If either the MATH or the custom display are added, it’s category 5.

Related Products & Solutions

Modular GM10

SMARTDAC+TM GM10 data logger has a modular architecture that can acquire necessary data. By supporting not only I/O but also many communication protocols such as 920MHz wireless, Modbus and so on. Monitor and setting changes are available through Bluetooth.
Supporting FDA 21 CFR Part11 and AMS2750E/NADCAP.

Touch Screen GP10/GP20

The SMARTDAC+TM GP10/GP20 is a portable paperless recorder with a modular architecture on the back panel and has a data logging function to acquire the required data. By supporting not only I/O but also many communication protocols, you can connect to various devices.
Supporting FDA 21 CFR Part11 and AMS2750E/NADCAP.

Touch Screen GX10/GX20

The SMARTDAC+TM GX10/GX20 is a panel mount paperless recorder with a modular architecture on the back panel and has a data logging function to acquire the required data. By supporting not only I/O but also many communication protocols, you can connect to various devices.
Supporting FDA 21 CFR Part11 and AMS2750E/NADCAP.

Top