An overview of FDA 21 CFR Part 11 compliance
FDA 21 CFR Part 11 sets forth regulations regarding electronic records and electronic signatures in industries regulated by the FDA, including pharmaceuticals, medical devices, biologics, and food and beverages. Compliance with 21 CFR Part 11 is particularly important for organizations that maintain electronic records and use electronic signatures in their operations.
Here's an overview of FDA 21 CFR
Part 11 compliance:
- Scope: 21 CFR Part 11 applies to records in electronic format that are created, modified, maintained, archived, retrieved, or transmitted under any FDA regulation. This includes records related to clinical trials, manufacturing, laboratory testing, and other regulated activities.
- Requirements: The regulation
outlines specific requirements for electronic records and electronic
signatures, including:
- Validation of
electronic systems to ensure accuracy, reliability, and consistency of
electronic records.
- Employing secure, computer-generated, and time-stamped audit trails for recording activities related to the
creation, modification, or deletion of electronic records.
- Use of electronic
signatures that are unique, attributable to the individual, and protected
from unauthorized use.
- Controls to ensure the
integrity of electronic records throughout their lifecycle, including
protection against unauthorized access, alteration, or deletion.
- Validation: Organizations subject
to 21 CFR Part 11 must validate their electronic systems to demonstrate
that they can meet the requirements of the regulation. This typically
involves a comprehensive validation process that includes testing,
documentation, and verification of system functionality and performance.
- Security Controls: Compliance with 21
CFR Part 11 requires the implementation of appropriate security controls to
safeguard electronic records and electronic signatures from unauthorized
access, tampering, or destruction. This may include access controls,
encryption, authentication mechanisms, and physical security measures.
- Audit Trails: Electronic systems
subject to 21 CFR Part 11 must maintain secure, computer-generated audit
trails that capture a record of all actions taken with respect to
electronic records, including who performed the action when it was
performed, and the nature of the action.
- Documentation: Organizations must
maintain accurate and complete documentation related to their compliance
with 21 CFR Part 11, including validation documentation, policies, procedures,
and records of electronic signatures and electronic records.
Non-compliance with 21 CFR Part
11 can result in regulatory enforcement actions, including warning letters,
fines, and product recalls. Therefore, organizations subject to the regulation
must ensure that their electronic systems and processes are designed,
implemented, and maintained in accordance with the requirements of 21 CFR Part
11.
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