21CFR11 Validation with EBRO
28/04/2006 - Cost effective measurement solutions for Temperature / rH / Pressure with user friendly software interface and report generation tools, resulting in quick and easy validation.
EBI series Data Loggers:
The Ebro logger range covers Temperature, Pressure, Temperature & Pressure combined and Temperature & Relative Humidity combined. These loggers are used for the measurement of :
- Sterilisers / Washer Disinfectors
- Freeze dryers / lyophilisers / Freezers / Refrigerators
- Dry heat ovens / Incubators / Depyronation Tunnels
- Cold rooms / Stability Chambers
The information gathered by our loggers is simply downloaded to our software. This is a powerful reporting and evaluation tool designed to meet the tough requirements of the pharmaceutical validation, qualification and measurement tasks. The software combines an easy to use user interface with an intuitive report generation to make your job easier.
Automatic functions are:
- Clear and concise reports are generated for setup and validation results. Reports can be further customised to meet user's specific reporting requirements. Data can also be exported to Excel for further analysis or processing
- The system comes pre-programmed with statistical, lethality, difference, fluctuations, variance and delta calculation capabilities. The user can select which calulations to use for their specific validation study
- The powerful cycle detective utility greatly simplifies report generation by automatically detecting and evaluating critical process cylces
- The software data base allows validations to be evaluated according to international and national regulations
- Explorer like template structure allows users to easliy create, select, store and manage the various devices and load configurations commonly validated. Revalidation is simplified by selecting a stored configuration from the template library.
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