21 CFR Part 1271

Records Management
• Must allow review of product history before distribution
and for follow-up purposes
• Must be system to promptly identify, locate and retrieve
records stored in multiple locations
• Records may be electronic, hard copy or copies but must
be equipment to make records readily available
• Retain for at least 10 years after product administration or
distribution (whichever is longer)
• Maintain list of all establishments performing a
manufacturing step (name, address & responsibilities)