Polarimetry software for 21 CFR Part 11

A Perkin Elmer LAS (UK) product story
Edited by the Laboratorytalk editorial team Feb 11, 2003

Developed after analysis of the FDA regulations and consultation with customers and industry experts, ensuring that regulated companies can prove the integrity of their electronic records

PerkinElmer Life and Analytical Sciences has introduced the POL WinLab Enhanced Security (ES) software for its series 341/343 polarimeters.

Ready for shipment now, this new software provides technical compliance with the Food and Drug Administration's (FDA) 21 CFR Part 11 regulations for pharmaceutical companies.

As part of PerkinElmer's suite of Enhanced Security products, POL WinLab ES was developed after thorough analysis of the FDA regulations and extensive consultation with customers and industry experts, ensuring that regulated companies can prove the integrity of their electronic records.

The thorough security implementation includes complete audit trails, password protected login and administrator-controlled user permissions to prevent unauthorised access.

Electronic signature points provide traceable approval and archiving of methods, results and reports, and allow organizations to realise the benefits of the paperless laboratory.

For rapid access, all data and methods are stored in secure databases allowing authorised users to manage and interpret results with maximum efficiency.

"Polarimetry is an analytical technique essential for the rapid measurement of the purity of compounds such as sugars, alkaloids and antibiotics that are used in pharmaceutical manufacturing, " explained Ken King, pharma QA/QC business leader at PerkinElmer Life and Analytical Sciences.

"As a market leader in polarimetry, we see the addition of POL WinLab as the tool that will allow customers to work in a more optimal way; creating faster, secure and easy-to-access electronic records." In addition to 21 CFR Part 11 Compliance, POL WinLab ES features robust pre-defined methods that simplify routine analysis, minimizing operator error and increasing confidence in results.

Methods include instrument settings, results calculations and customized, flexible report templates.

For further assurance, an automated instrument validation module ensures that instrument performance is measured at regular intervals in accordance with the Good Laboratory Practice (GLP) guidelines.

POL WinLab ES is also available as a standard version, POL WinLab, for non-regulated industries.

Both versions control the model 341 and model 343 Polarimeters, and run on the Windows 2000 operating system.

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