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21 CFR Part 11
A complete set of resources for 21 CFR Part 11
21 CFR 11.10(a)
Validation of computer systems
21 CFR 11.10(b)
Accurate Generation of Records
21 CFR 11.10(c)
Protection of Records
21 CFR 11.10(d)
Limited System Access
21 CFR 11.10(e)
Audit Trails
21 CFR 11.10(f)
Operational System Checks
21 CFR 11.10(g)
Authority Checks
21 CFR 11.10(h)
Input Checks
21 CFR 11.10(i)
Education, Training and Experience
21 CFR 11.10(j)
Policies for Electronic Signatures
21 CFR 11.10(k)
Document Control
Part 11 FAQ
Validation of computer systems
Validation Resources
On selected validation documents
Validation Planning
Requirement Gathering
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Installation Qualification
Summary Report
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