FDA 21 CFR Part 11 ERES Checklists

 21 CFR Part 11 Checklists. We've come a long way....or have we? The year is 1997. Bill Clinton is in his second term,

Windows 95 is revolutionary, a laptop only weighs 6-8 pounds and 21 CFR Part 11, the US Food and Drug Administration's (FDA) regulation on electronic records and electronic signatures went into effect (enforcement to begin in 2001).  Two decades ago, most software used in the life-sciences industry was not compliant and many to most quality processes were managed via paper record. Read more.

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