FDA Regulation 21 CFR Part 11 Compliance

Posted on: July 11th, 2019

The U.S. Food and Drug Administration (FDA) regulates a variety of industries. Title 21 CFR Part 11, the Electronic Records and Electronic Signatures ruling, is one of the more important FDA regulations pertaining to spectroscopy in industries subject to USDA oversight. This important FDA regulation provides for guidance on the types of software allowed for use in controlling the operation of, and recording of data from, an instrument or device. Because spectrometers can be used in drug discovery, quality control, and a multitude of medical applications, they are subject to comply with 21 CFR when used in specific applications.

Pharmaceutical technician in a sterile environment working on the production of pills at pharmacy factory

To meet the requirements of the 21 CFR Part 11 ruling, Avantes has partnered with the German analytical software company, LabCognition, to offer Panorama Pro software as an alternative to AvaSoft software and provides full control of Avantes spectrometers for UV/VIS and NIR wavelengths.

Meet FDA Regulation Compliance with Avantes

Panorama Pro, with the purchase of its security add-on module, provides full compliance with 21 CFR Part 11. This robust software application provides for mathematical spectral corrections, multivariate chemometric modeling, spectral library access, and a variety of other functions. The additional security module provides data access control and permission schemes based on built-in user administration that features hierarchical permission levels. System users may access only the program functions and data allowed by their user profile, which can be set to allow the workflow-oriented release of data objects according to a company’s organizational structure. All user activities, such as log on, log off, changing options, creating, modifying, or removing data, etc., are logged in a comprehensive activity report which can be reviewed by the system administrator in a report, or used during a company FDA regulation compliance audit.

For more information or a demo of Panorama Pro software, or any of Avantes’ software solutions, with an Avantes spectrometer, please visit us at [email protected] or phone us at 1-866-678-4248.