Posted to News on 10th Sep 2007, 19:17
Comprehensive range of products and systems for life sciences
Eurotherm offers what it claims is the most comprehensive range of products and systems available from one supplier for use by the pharmaceutical and bio-pharma industries. These include DCS packages, data management systems, data recorders, discrete controllers, indicators and signal conditioning.
For over 30 years Eurotherm has been involved in all aspects of these industries, including hydrogenation, water purification, mixing and blending, sterilisation, spraying, fermentation, freeze drying, tablet formation and time synchronisation. As a result, the company's products have been successfully validated by worldwide regulatory bodies including the FDA, MCA and EMEA.
When used correctly, Eurotherm's data recorders and DCS systems have electronic signature and electronic record capability that conforms to the requirements of FDA 21 CFR Part II. The controllers have a lockout feature that permits changes through a 21 CFR Part 11 compliant operator station, thereby providing the necessary audit trail.
Tamperproof electronic records include: process values and audit trails (alarms, events, electronic signatures), date and time stamping, time synchronisation, and a facility for converting data and exporting it to Excel spreadsheets.
The electronic signature function includes user actions with signing and authorisation, unique signatures required, automatic log-off, minimum length password, access control according to authority level, and automatic password expiry.
