Download 21CFR Information

We recognize that meeting & remaining compliant with FDA 21 CFR Part 11and international standards is important to your business. OFFICE PLM, a .net Document Management System, automates and seamlessly manages your document control process to ensure compliance with these regulations. Office PLM is specifically designed for organizations that design what they make, where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.

Office PLM is specifically designed to manage, store and integrate Parts, Documents and Business Process to ERP systems. Organizations that need seamless integration to all business systems and process visibility need Office PLM. 

Office PLM manages the entire document life-cycle process and gives you the tools to securely manage a wide range of business documents, including those related to regulated environments.

Office PLM is a fully 21 CFR Part 11 compliant document management solution based on Microsoft Windows .net technology. Office PLM is designed specifically for management of SOPs, Work Instructions, and other documents within business areas regulated by the FDA.