R Thread Starter Rashid S. Aidun May 21, 2001 #1 I like to know how I can obtain a document which details the FDA requirements for controls and machinery design.
I like to know how I can obtain a document which details the FDA requirements for controls and machinery design.
L Larry May 21, 2001 #2 This is a long subject. You'll be looking for CFR 21 Part 11 compliance. GAMP is a good place to start, available at http://www.ispe.org . Expect to pay a couple hundred bucks for the documents, but in the end it's worth it. Larry
This is a long subject. You'll be looking for CFR 21 Part 11 compliance. GAMP is a good place to start, available at http://www.ispe.org . Expect to pay a couple hundred bucks for the documents, but in the end it's worth it. Larry
