Revol LIMS 21 CFR Part 11/ Annex 11 Compliance

How Revol LIMS helps laboratories to automate and streamline their workflows and enhance their data quality and security

Executive Summary:

The document is about the 21 CFR Part 11 and Annex 11 compliance of Revol LIMS software, a web-based laboratory information management system that offers a comprehensive and integrated solution for managing the entire laboratory workflow.

The document explains how Revol LIMS software helps laboratories to comply with the regulations for electronic records and electronic signatures issued by the U.S. Food and Drug Administration (FDA) and the European Union (EU).

These regulations are designed to ensure the reliability, authenticity, integrity, and availability of electronic records and signatures used in regulated industries, such as pharmaceuticals, biotechnology, medical devices, food and beverage, etc.

The document also lists and explains the features and functionalities of Revol LIMS software that support compliance, such as role-based security, electronic signature, audit trail, data integrity, data availability, etc.

Share On