Recipient: Guidant CorpProduct: Insignia Pacemaker Date: 9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended use according to an established...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.