Case Study

Case Study: Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System

Source: AssurX, Inc.

When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for. Bausch & Lomb, founded in 1853 and headquartered in Rochester, NY, is a leading global vision care company. Today, the company has over $1.5 billion in annual revenues, over 10,000 employees in 35 countries, with products distributed in over 100 countries. systems, home grown applications, as well as two competitive software products.

21 CFR Part 11 compliance was a key factor in Mueller's decision. Bausch & Lomb had already created a position paper on 21 CFR Part 11 requirements.

PDF format.