Package software to support data integrity
CISAS/ER is a package software that allows data recorded by our graphic recorder and wireless loggers to be centrally managed on a computer and managed as electronic records that comply with the requirements of FDA 21 CFR Part 11.
The following measurement data can be managed as electronic records:
- Graphic recorder with measurement data protection function (KR2000/KR3000 series) data*1
- Data from a wireless watcher with security function (wireless logger MD8000 series) *2
- Data on equipment compatible with the data acquisition and monitoring package system (CISAS/V4)
*1 If Part 11 is not supported, graphic recorder (KR2000/3000 series) data without protection function can also be used.
*2 If Part 11 is not supported, data from a wireless watcher (wireless logger MD8000 series) without security functions can also be used.
