Compliance Group

  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 .

  the  FDA New, draft guidance on Computer Software Assurance (CSA) Guidance  gains traction, more and more organizations are recognizing the value of a leaner approach and for those that have already implemented CSA, they're realizing it. Earlier this year I had a two-and-one-half hour discussion with a Validation Manager at a large pharmaceutical manufacturer, responsible for validation at over 50 global sites. Read more