PerkinElmer Life and Analytical Sciences has developed three new software packages designed to meet the FDA's 21 CFR Part 11 regulation.
PerkinElmer Life and Analytical Sciences has developed three new software packages designed to meet the FDA's 21 CFR Part 11 regulation.
These software solutions are for the MicroBeta and TopCount microplate readers, as well as for PerkinElmer's two new Flow Scintillation Analyzers, the Radiomatic 610TR and the Radiomatic 625TR.
These new offerings are the first of many new software packages PerkinElmer plans to introduce in the coming months.
The Food and Drug Administration's (FDA) Electronic Records and Signatures regulation is known as 21 CFR Part 11.
Compliance with 21 CFR Part 11 is mandatory for businesses operating under GMP, GLP or GCP guidelines, which includes companies developing or manufacturing prescription pharmaceutical compounds for sale in the United States. PerkinElmer's MicroBeta and TopCount instruments are widely used in pharmaceutical and biotechnology companies in their drug discovery efforts.
The new software solutions offer user-friendly Microsoft Windows features, thus requiring minimal or no training.
Electronic record (data) security, instrument access and audit log access control are additional features promoting compliance.
Existing instruments can be upgraded with either software in the laboratory, reducing downtime while increasing productivity.
New MicroBeta and TopCount instruments will offer the 21 CFR Part 11 compatible software as an optional feature.
A unique combination of state-of-the-art scintillation counting technology and interchangeable beta/gamma/positron emission detectors has made the Radiomatic series the most versatile radio-HPLC detector on the market.
These new Radiomatic products offer ProFSA Plus software as an option with new instrument shipments.
ProFSA software is designed to fully support GLP and associated regulatory requirements for both laboratory operations and laboratory software design including 21 CFR Part 11 compatibility.
"We understand our customers require faster and easier solutions in this ever-changing business environment," said Paul Gillyon, vice president and general manager, Biopharmaceutical, PerkinElmer Life and Analytical Sciences.
"PerkinElmer is committed to helping its customers meet the FDA's compliance regulations with these new software products.
We plan to offer 21 CFR compatible software for our full portfolio of plate readers and microplate imagers, which are widely used in the pharmaceutical and biotechnology industry."
