21 CFR PART

11
Ayesha Fatima
 What is 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]
• 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
 3 sub parts

01 02
SUB PART A SUB PART B
General Provisions Electronic Provsions
• Scope • Controls for closed systems
• Implementation • Controls for open systems
• Definitions • Signature manifestations
• Signature/record linking

03
SUB PART C
Electronic Signatures

• General requirements
• Electronic signature components and controls
• Controls for identification codes/passwords
 A world without CFR 21 PART 11
As the world becomes increasingly digitalized, working without
electronic forms and being compliant with GCP, FDA regulations
would be more challenging to meet. A vast amount of paper
documentation would be required to monitor and store vast
quantities of data in accordance with FDA's requirements.
 IMPACT

TIMELINE
• 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.
• It is stated [4] that compliance with part 11 can reduce study-building
and database lock times by 21-42%.[5]

SECURITY
• While paper documents can technically be stored in a secure physical
location, in reality, they are often far less secure compared to data
stored in the cloud. Physical documents are frequently left lying
around on desks or may be transported in briefcases, which can
increase the risk of data breaches. Additionally, physical documents
must be transferred to a central location, which poses a significant
security risk. Handwritten signatures are also a major security threat
as they can be more easily forged or impersonated.[2][3].
DOCUMENATION

• An audit trail is a chronological record of electronic activities that are related to a

specific operation or event. These records provide a detailed history of electronic
records and electronic signatures, which helps to ensure the integrity,
authenticity, and security of data. Due to the absence of 21 CFR Part 11, no audit
trails would be subjected.

• Without these guidelines, researchers and pharmaceutical industries would have

to rely on paper-based records, which can be easily lost, damaged, or altered,
leading to data integrity issues. This would result in a lack of trust in research
findings and ultimately hinder the progress of academic research.
 21 CFR PART 11 BENEFITS
• CFR 21 part 11 is a set of guidelines
that establish the requirements for
electronic records and electronic
signatures in the pharmaceutical and
medical device industries.
• These guidelines provide a
framework for ensuring the security
and integrity of data and have
numerous benefits. For example

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 How does 21 CFR part 11 benefit CDM operations?
DATA SECURITY

• The validation process for computerized systems ensures that they are
reliable, consistent, and secure. This reduces the risk of errors, prevents
data loss, and ensures that the system operates as intended are
accessed only by authorized bodies.[4]

DATA INTEGRITY

• Data integrity safeguards are another significant benefit of CFR 21 part 11.
The guidelines mandate the use of electronic signatures and audit trails,
which ensure that data cannot be tampered with or modified without
proper authorization. These measures help to prevent fraud and ensure
the accuracy and completeness of data.
 Benefits

• A significant benefit of CFR 21 part 11 is that it allows for system backup

and disaster recovery. By having a system backup in place, businesses can
easily restore data in the event of a disaster or system failure, thus
•
minimizing any disruption of operations.

DOCUMENTATION
• The use of audit trails and audit record retention has many benefits,
including the ability to detect and prevent unauthorised changes to data,
ensure the accuracy and completeness of data, and maintain data integrity.
Additionally, these records can be used to identify potential security
breaches or issues with the system, helping businesses to improve their
overall security posture.
 Conclusion
• CFR 21 part 11 is a set of guidelines that establish the requirements for electronic
records and electronic signatures in the pharmaceutical and medical device
industries.
• Overall, it is clear that the benefits of using paper CRFs do not hold up in the long
run. With clinical trials becoming expensive, companies should rely on streamlining
as many processes as possible. Using electronic 21CRF PART 11 compliant
documents for collecting and storing clinical data, therefore, seems to be a simple
choice [4][5].
• In particular, using electronic records and signatures can specifically lower clinical
trial costs by improving data quality and lower monitoring costs. Trial timelines can
be shortened by reducing study-building and database lock times. Therefore, a lot
of companies in the industry, patients, and researchers would benefit from being
compliant with 21 CRF part 11.
 References
1. United States Food and Drug Administration, Title 21 Code of Federal
Regulations Part 11. Good Laboratory Practice for Non-Clinical Laboratory
Studies, 1994.
2. McDowall, R. D. (2000). Electronic Signatures and Logical Security. LC GC
EUROPE, 13(5), 331-339.
3. R. D. McDowall (2002). The impact of 21 CFR 11 (Electronic records and
electronic signatures final rule) on bioanalysis. , 55(1 Supplement), S85–S90.
doi:10.1007/bf02493360
4. http://vertassets.blob.core.windows.net/download/733581ee/733581ee-a56d-
4408-b5b7-3e19b1325b1b/reducingtimetomarketwitheclinicalsystem.pdf
5. https://www.castoredc.com/blog/paper-crfs-vs-ecrfs/
Thank You