Company: St. Gobain Ceramiques Avancees Desmarquest
Product: Medical Devices
Date: 4/26/02

You need to property validate the … furnace process. Please supply a complete proposed validation protocol for the … furnace. This protocol should specifically address if any aspect of this furnace is computer controlled and how the software will be validated. Enclosed are copies of the Process Validation Guidance issued by the Global Harmonization Task Force Study Group 3, the FDA’s May 11, 1987, Federal Register Notice issuing guidance on General Principles of Process Validation and the FDA’s “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” dated January 11, 2002, to aid you in developing your protocol.

Issuer: Center for Biologics Evaluation and Research (CBER)