Product category:
Nucleic acid sequencing and synthesis
News Release from: Tecan Group | Subject: Gemini 4.1, Magellan Tracker 4.0
Edited by the Laboratorytalk Editorial
Team on 12 June 2003
Software helps meet 21 CFR Part 11
Pipetting software for life science applications and instrument control and data reduction software for detection products upgraded to meet the FDA regulation
Tecan has recently announced the release of Gemini 4.1 and Magellan Tracker 4.0 to help companies comply with the new FDA 21 CFR Part 11 regulations These software packages allow customers to implement electronic records and signatures according to FDA regulations and are suitable for many Tecan solutions used in the pharmaceutical and biotechnology industry
This article was originally published on Laboratorytalk on 23 May 2002 at 8.00am (UK)
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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.
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 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.
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 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.
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