Quality in the Pharmaceutical industry has always been highly regulated by various drug control agencies. Governing bodies, like the FDA, have set strict guidelines to minimize errors and improve reproducibility in the process. ISO, GLP, GMP, and GAMP incorporate the same guidelines to achieve process excellence. The very importance of XiltriX is to proportion data in order to clearly understand process deviations and correct them at the critical times.
XiltriX provides data on all procedures and processes for complete traceability from temperature and relative humidity to particle counting and volatile organic compounds (VOCs). The data covers all equipment and environmental parameters. Via automatic alarms users are informed of any deviations. Full audit trails and alarm data make the system compliant to the aforementioned regulatory guidelines. With the addition of our compliance and validation services, XiltriX continually protects your Science.
“The system gives us the security that we are in constant control of all our equipment and rooms and, if there are any deviations, we will be notified and appropriate action can be undertaken.”