PerkinElmer Life and Analytical Sciences has announced the availability of two new Radiomatic Flow Scintillation Detectors for HPLC - the Radiomatic 610TR and the Radiomatic 625TR.
PerkinElmer Life and Analytical Sciences has announced the availability of two new Radiomatic Flow Scintillation Detectors for HPLC - the Radiomatic 610TR and the Radiomatic 625TR.
Key to these new products is the enhanced radiochromatography software packages -- ProFSA and ProFSA Plus -- that add important new functionality and regulatory compliance support.
ProFSA and ProFSA Plus offer a complete approach to method development, direct instrument control, data evaluation, report generation, and hands-off automation.
Important features of the enhanced software include: * 21 CFR Part 11 technical compliance - for additional security and regulatory compliance, ProFSA Plus is designed to fully support Good Laboratory Practices (GLP) and associated regulatory requirements for both laboratory operations and laboratory software design, including 21 CFR Part 11 compliance.
* User-friendly set-up Wizards provide instruction on the use of major instrument functions, including instrument configuration, detector set up, calibration and reporting.
* ProFSA software uses quick graphical icon-driven tool bars with single keystroke operation and on-screen prompt lines to simplify the operation and provide access to information.
* A single software package can be easily integrated into any existing High Pressure Liquid Chromatography (HPLC) workstation to provide simultaneous operation and a seamless interface eliminating the need for an additional computer.
* Fully networkable 32-bit software with multiple trace display and treatment, quench correction, decay correction, manual and automatic peak finding, continuous and discontinuous pump control and fraction control.
* A complete evaluation package allows both automatic batch analysis and manual evaluation of measurement and evaluation files.
Key components of ProFSA Plus include: * Configurable password and user ID protected log in.
* Access level security controls provide access to menu items and form-level functions to guard against unauthorized access to data.
* Functionality to meet with the FDA 21 CFR Part 11 ruling for electronic signatures and electronic records with system manager configurable control of signature points on key events.
* Complete GLP audit facilities provide a complete audit trail of analytical and method changes.
Audit events are selectable in order to allow the user to define key critical data modification points that require audit.
* An extensive document management system is also included, which provides seamless integration of data, tables, graphs, and text into final reports through an automated link to Microsoft Word.
"Many of our customers are currently addressing the challenges associated with meeting regulatory requirements," said Paul Gillyon, vice president and general manager, Biopharmaceutical, PerkinElmer Life and Analytical Sciences.
"The new Radiomatic Flow Scintillation Detectors and updated software provide a simple and cost-effective means for equipping their laboratories with systems compliant with FDA regulations."
