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April 25, 2003 | Customer News

FDA 21 CFR Part 11 regulations – Tecan launches two new software solutions

  • Gemini 4.1 and Magellan Tracker 4.0 allow customers to implement electronic records and signatures according to FDA regulations
  • New software suitable for many Tecan solutions widely used in the pharmaceutical and biotechnology industries

Zurich, Switzerland, 25 April 2003 - Tecan, a leading player in the Life Sciences supply industry, today announced the release of Gemini 4.1 and Magellan Tracker 4.0. These new software solutions have been designed for customers who need to meet the FDA’s 21 CFR Part 11 Regulations.

An increasing number of laboratories have to comply with the FDA’s 21 CFR Part 11 ruling on Electronic Records and Signatures. The regulation sets out to ensure that electronic data (records) are authenticated and free from unauthorised changes. This poses additional requirements on software in the areas of user management, authentication, electronic signature, audit trail, and data security that are now fully implemented in Gemini 4.1 and Magellan Tracker 4.0. Compliance with 21 CFR Part 11 is mandatory for customers who wish to use Electronic Records or Signatures in a Good Manufacturing Practice (GMP) environment.

Gemini is Tecan's pipetting software for life science applications on the Genesis RSP, Genesis Freedom and the Genesis Workstation platforms. These applications include those enabled by Tecan’s Te-MO™ multi-channel pipettors. Use of Gemini 4.1 software will offer Tecan’s customers enhanced features facilitating the day-to-day use of the Te-MO™ family of multi-channel pipettors. Magellan is Tecan’s comprehensive instrument control and data reduction software for detection products, ranging from Sunrise to the new Ultra Evolution. Magellan Tracker 4.0 includes improved on-screen user instructions (wizards) that significantly improve ease-of-use at all levels of operation.

Dr. Achim Wehren, Biopharma Marketing Manager at Tecan, commented: “One of the key drivers in our industry is to provide solutions that are not only faster but which are also easy to use and which meet the highest possible regulatory standards. We are delighted to announce the introduction of Gemini 4.1 and Magellan Tracker 4.0 Software for customers working in regulated environments. These solutions will enable users to fully meet the 21 CFR Part 11 compliance requirements of the FDA and to improve the speed and quality of their operations.”

The new software options are available with Tecan’s current portfolio of solutions for the Life Sciences or may be introduced as an upgrade for previously installed instruments.
For more information about Tecan’s new software solutions, contact your local Tecan representative.

More details on the 21 CFR Part 11 regulations can be found at www.fda.gov/ora/compliance_ref/part11

For more information, please contact:


Product Information:

Cornelia Kegele
Manager Marketing Communications and Branding
Tel.: +41 (0)44 922 81 11
Fax: +41 (0)44 922 82 81
Editorial contact for additional information or follow-up:
Barry Whyte at Rochat & Partners, Geneva, Switzerland
Tel.: +41 (0)22 786 54 55 Fax: +41 (0)22 786 54 58 e-mail barry@rochat-pr.ch


Investor Relations:

Christophe Lamps
Rochat & Partners
Tel.: +41 (0)22 786 54 55
Fax: +41 (0)22 786 54 58
e-mail: clamps@rochat-pr.ch