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Information Security
21 CFR Part 11 Compliance Checklist
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21 CFR Part 11 Compliance Checklist

1
Identify electronic systems requiring 21 CFR Part 11 compliance
2
Document system functional details
3
List all electronic records generated by the systems
4
Determine the criticality of each electronic record
5
Define access control requirements per system user roles
6
Assess existing electronic signature capabilities
7
Evaluate existing record retention and retrieval capabilities
8
Review and document system Audit trail capabilities
9
Approval: Electronic System Assessment
10
Implement required system updates for compliance
11
Establish procedures for system use
12
Train users on how to operate the system in a compliant manner
13
Approval: Compliance Training
14
Perform a validation of the updated systems
15
Draft validation protocol
16
Approval: Validation Protocol Draft
17
Perform validation tests and document results
18
Approval: Validation Test Results
19
Perform a review of system logs and system responses
20
Finalization of 21 CFR Part 11 Compliance Checklist