Thermal Process Validation System

XpertVal

XpertVal is a stand-alone thermal validation system that simplifies the entire validation process by:
- significantly reducing setup
- minimizing sensor handling
- presenting critical study data in easily customized report formats.
This advanced system is specifically designed to conform with new FDA electronic records guidelines (21 CFR Part 11) and meet international and European norms for validation of pharmaceutical, biotechnology and medical device (EN 285, EN 554) manufacturing plants.
Continuous evolution of the pharmaceutical, biotechnology, medical equipment market and international regulations request more reliability and best performance of the Thermal Validation Systems.
The complex equipment controlled by the computer has the ability to help the final user to improve his validations of thermal process.
Validation of software; IQ & OQ, training the user; 21 CFR part 11 compliant; prompt and high quality Service After Sales are few of the methods applied by LIVES International to allow XpertVal users to obtain the highest degree of comfort and confidence XpertVal thermal validation system.
XpertVal System saves time and offers safety features by:
- hands free thermocouple calibration before and after the test
- quick training
- user friendly
- automatic reports generation (calibration , test , post calibration)
- real time trending
- statistics after the test
- 21 CFR Part 11
Raw data is encrypted and double protected on a PCMCIA card and in a file on the hard disk. The system meets European and American requirements concerning thermal validation processes, electronic data protection and data signature.

 
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