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Pharmaceutical Solutions

 

Scalable solutions from Sensors to Systems
The most complete set of products from a single supplier.

Eurotherm offers a comprehensive range of solutions for Pharmaceutical and Bio-Pharma industries, which include temperature controllers, process control systems, data recorders, data management systems, indicators and signal conditioning.

More than 30 years experience

Our products have been used in a wide range of pharmaceutical applications, in both standalone and as part of an integrated system, that have been successfully validated by the regulatory bodies around the world including: FDA, MCA and EMEA.

Meeting the requirements of 21 CFR Part 11

Eurotherm Data recorders and process control systems have Electronic Signature and Electronic Record capability. The controllers have a lockout feature that permits changes through a 21 CFR Part 11 compliant operator station, thus providing the necessary audit trail.

Tamperproof Electronic Records

  • Process Values and Audit Trails
    (Alarms, Events, Electronic Signatures)
  • Date and Time stamped
  • Time Synchronisation
  • Viewable in human readable format
  • Export conversion facility to Excel

Electronic Signature

  • User actions with signing and authorisation
  • Unique signatures required
  • Automatic Log-off
  • Minimum length password
  • Access control according to authority level
  • Automatic password expiry

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Last updated March 1, 2004