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Home » Guidant Responds to Form 483; Emphasizes Part 11 Controls
Guidant Responds to Form 483; Emphasizes Part 11 Controls
December 1, 2005
While Guidant said it disagrees with the FDA’s recent observation of apparent software validation and electronic records control violations, the company also noted it would examine and strengthen relevant in-house requirements and implementation guidelines to ensure compliance with 21 CFR Part 11.