New software solutions have been designed for customers who need to meet the FDA's 21 CFR Part 11 regulations
Tecan UK has 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.
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.
The introduction of Gemini 4.1 and Magellan Tracker 4.0 provides customers with software solutions that are not only faster but which are also easy to use and which meet the highest possible regulatory standards.
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.
