Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System
•Case Study: Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System
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.
Bausch & Lomb is divided into (5) business units
comprised of:
- Contact lenses
- Lens care
- Cataract and vitreoretinal surgery (surgical products)
- Refractive surgical products (lasers)
- Pharmaceutical products – including generic and proprietary prescription pharmaceuticals, mostly in the ophthalmic field, over-the-counter eye drops and other medications.
Mueller's planning process identified three key
criteria that had to be met:
- The ability to manage all CAPAs on both a local and global level – local facilities would log site-specific issues, but site managers needed to share knowledge among multiple facilities.
- The system must provide a central repository of all CAPAs for all facilities so that Global Quality Assurance could manage and track all issues throughout the organization.
- 21 CFR Part 11 compliance – CAPA system had to provide electronic signatures, time-stamped audit trails, security controls, etc.
Mueller chose CATSWeb, from AssurX Inc. By the end of 2002, CATSWeb will be rolled out to all 40 global facilities, replacing paper-based 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. In addition to developing policies, procedures and remediation plans to bring all existing systems into compliance, Bausch & Lomb performed gap analyses on various commercial offerings. According to Mr. Mueller, "We felt CATSWeb was above and beyond in compliance with 21 CFR Part 11 requirements. And we have a very strict interpretation of those requirements."
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•Case Study: Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System
SOURCE: AssurX, Inc.