When 21 CFR Part 11 was introduced in 1997, it created in equal measure - confusion and consultants. Fourteen years on, the confusion has largely disappeared and while regulation remains under review the chances of wholesale changes are highly unlikely. The cottage industry of consultants remains though, eager to serve for three months and leave a pile of validation protocols in their wake. While there are many competent hardworking consultants out there, there are many yet, who by virtue of their profession, have never sat in front of FDA or EMEA, have never had to defend last weeks, last month, or last years validation package.
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