CFR 21 Part 11

CFR 21 Part 11 is a regulation issued by FDA. It defines the conditions under which organizations may submit or store FDA-related documents in electronic form instead of on paper. The regulation focuses on ensuring that electronic records are as reliable and trustworthy as their paper equivalents.

The key requirements include:

• System validation
• Controlled access - records must be accessible only to authorized personnel
• Audit trail - documentation of all modifications to electronic records
• Electronic signatures

Compliance with CFR 21 Part 11 can only be achieved through a combination of the appropriate software functionality, system configuration, and standard operating procedures (SOPs) defined by the organization.