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Home » Guidant's Response to Form 483 Emphasizes Part 11 Controls
Guidant's Response to Form 483 Emphasizes Part 11 Controls
November 23, 2005
Although Guidant disagreed with the FDA’s recent observation of apparent software validation and electronic records control violations, the company said it would examine and strengthen the relevant in-house requirements and implementation guidelines to ensure compliance with 21 CFR Part 11.