21 CFR PART 11

Ayesha Fatima
Introduction to 21 CFR Part 11

• The United States Code of Federal Regulations (CFR) Part 11, also
known as the Electronic Records and Signatures Regulation, is a
section of the regulatory framework established by the Food and Drug
Administration (FDA) to protect the integrity of electronic records
used by the pharmaceutical industry.[1] fda
• 21 CFR part 11 was introduced by the FDA upon seeing the
advancement and the quantity of data one is working with.
• Before the introduction of CFR Part 11, the pharmaceutical industry
relied on paper copies and handwritten signatures
2. Overview of 21 CFR Part 11

• CFR has three sub-parts and monitors work with electronic records
and signatures
• CFR sets easy to work with guidelines providing standardized
documents and protocol
A world without 21 CFR PART 11
• As the world would grow more and more digitalised, working without
electronic forms and being compliant with GCP, FDA regulations would be
harder to meet. We would be stuck with monitoring and storing huge
forms of data in paper copies as required by FDA.
• During the study-building phase and in between the clinical phases the
processes would not be streamlined as superfluous documents would be
circulated, and forms that could be reused would have to be redone from
scratch leaving the statistical team waiting for days.
• Accordingly [], it states that compliance with part 11 reduced the time by
study-building and database-lock times can be reduced by 27-41% and
41-65% respectively.
• One seeming benefit of storing clinical trial data on paper is that it can be
securely locked away from outside access. Paper can indeed be stored in a
physical vault, but in practice its use is often far less secure than data stored in
the cloud. Documents often lie around on staff desks, or end up in a briefcase.
Documents also need to be physically transferred to a central location, which
poses a security risk. Using a cloud-based EDC system mitigates these risks by
using military-grade data security (ISO 27001, HIPAA), off-site backups, and
transferring data using SSL encryption. Confidentiality is safe-guarded through
flexible user management and an audit-trail. These features also enable your
company to meet GCP compliance requirements for best clinical practice.
• Paper can indeed be stored in a physical vault, but in practice its use is
often far less secure than data stored in the cloud. Documents often
lie around on staff desks, or end up in a briefcase. Documents also
need to be physically transferred to a central location, which poses
a security risk,
4. Requirements of 21 CFR Part 11
BENEFITS OF CFR PART 11
• Security
• Centralises, cloud backed up data
• The system is validated meaning the system has limited access, a defined process
allowing , encrypted data
• Data Integrity Safeguards
• System Backup and Disaster Recovery
• Validation of Computerized Systems

• Audit Trails
• Auditing & Record Retention
3. Scope & Application and need of 21 CFR Part 11

• Electronic Signatures

• copies
16. Examples of 21 CFR Part 11 in Practice
Conclusion
References

• https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/part-11-electronic-records-electronic-signatures-scope-
and-application(Part 11, Electronic Records; Electronic Signatures -
Scope and Application)
• https://www.govinfo.gov/content/pkg/CFR-2022-title21-vol1/pdf/
CFR-2022-title21-vol1-part11.pdf
THANK YOU