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.