May 22 2015

Compliancy with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures

Your industries demand compliance and your staff need training and certification. Percepium has the solution to help your organization to manage learning and development in compliance with regulations and the 21 CFR Part 11 of the Code of U.S. Federal Regulations in specific. Our development team proudly announce that our LMS has been enhanced to be compliant with the U.S Food and Drug Administration´s 21 CFR Part 11 Electronic Records; Electronic Signatures. Since this is a rigorous regulation governed by the FDA only a few Learning Management Systems can meet the requirements and conform to the standard.

It´s another confirmation that our solution meet complex industry standards and that we are now competitive and a vendor of choice in the regulatory training space in US and other markets“, says Ola Badersten CEO Percepium.

Regulations require organizations to demonstrate that their personell have the appropriate combination of education, training and experience to do their assigned jobs. Training records are very often reviewed during inspections. Mulitnational organizations have in addition to deal with different regulations and regulatory bodies. Percepium LMS is the ideal solution to adress multiple regulators so your organization can keep track and ensure regulatory compliance. We allow organizations to meet Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) for training records.

Other regulations that apply in U.S. for the management of traning records are:

-21 CFR Part 820

-21 CFR Part 58

-21 CFR Part 211