Method

For mainly pharmaceutical clients most applications will require the use of advanced software i.e. ValSuite™ Pro with its 21 CFR Part 11 compliance and sophisticated reports and features. For process monitoring creating a Unit with exact positioning of each measuring point is mandatory when handling that many sample points. Further adding it all up in a Profile including a Limit Report as well as Statistical Report is useful and very time saving.

For validation an even higher number of sampling points is needed which is why using a Profile and a Unit is recommended. The same Limit Report and Statistical Report is required to analyze the data. When validating the SIP system, the Validation or even the Advanced Validation Report is perfect.

At the end of each study, report(s) can be signed by Electronic Signature(s) and stored, printed or distributed in secure and locked PDF format.

With regular intervals each probe or sensor can be calibrated or verified using the built in calibration functionality in the ValSuite™ Pro software which also issues a Calibration Report on demand and this ensures that all measurements are made within the tolerances required. A factory calibartion with a traceable calibration certificate is recommended every 12 months for all Ellab sensors.