Case Study: SDI (biotechnology firm) achieves ISO 9001 compliance and streamlined document control with Intelex Quality Management Software

Biotechnology Firm Meets ISO 9001 Requirements Using Intelex Quality Management Software

A biotechnology firm needed to achieve ISO 9001 compliance to enable future certification and stabilize business processes across roughly 150 users. They faced paper-based workflows, inefficient document distribution, the requirement to meet FDA (CFR Part 11) criteria for electronic records and signatures, and the need for a system that could adapt to ongoing reorganization.

The company implemented Intelex’s Quality Management System with a strong focus on Document Control (over 3,000 documents loaded), supported by tailored on-site training, responsive client services, and online resources; nonconformance, audit, and communication modules are being rolled out. The solution delivered ISO 9001 compliance, centralized and stabilized document management, met CFR Part 11 requirements, and positioned the organization to support its evolving structure and processes.

SDI

Jason Usilton

Quality Supervisor