Professional Documents
Culture Documents
CFR Part 11
CFR Part 11
Pawar
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CONTENTS
CONTENTS
•
•
•Introduction
•Introduction
•Importance
•Importance
Part11-electronic records & Part11-electronic records
•signatures
•SubpartA:General SubpartA:General Provisions
Provisions SubpartB:Electronic SubpartB:Electronic
Records
•Records
•SubpartC:Electronic SubpartC:Electronic Signatures
Signatures
Conclusion
•Conclusion
•References
References
•
•
•
•
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Code of Federal Regulation is the codification of the general and permanent
rules and regulations published in the Federal Register by the executive
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21 CFR Part 11 is an important section of the Code of Federal Regulations
21 CFR Part 11 deals with rules for electronic records and electronic
signatures as set out by the FDA
It need to be understood that each title and part of the CFR denotes a certain
industry or activity
21 CFR is the FDA title for PHARMA and medical devices, while Part 11
relates to a specific activity, namely electronic signatures and record
In 1999, computerized system that are used in clinical trials came under 21
CFR Part 11
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CFR 21 Part 11
ELECTRONIC ELECTRONIC
RECORDS SIGNATURE
S
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Subpart A-
• 11.1-Scope
General • 11.2-Implementation
• 11.3-Defination
Provisions
Subpart C-
Electronic •11.100-General requirement •11.300-
•11.200-Electronic signature components
Signatures Identification codes/passwords
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11.1 Scope-
Recordsretrieved,
archived, in electronic form that are created, modified, maintained,
or transmitted,
Electronic signatures to be equivalent to handwritten signatures,
and other general signing
Electronic records may be use in place of paper records
Computer
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A. For records required to be maintained but not submitted to the
agency…..provided that the requirements of this part are met.
B.
For record submitted to agency
1. the requirements of this part are met
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Electronic record–
Electronic signature -
combination of text, computer data of any Digitalsignature-
graphics,data,audio, symbol executed by an electronic signature base
pictorial, or other individual to be the on cryptographic
information represent individual written method
digital form it is signature
modified
Biometrics- verifying
Handwritten signature-the act individual identity base on
of signing with a writing or
marking instrument such as individualphysicalfeature or
penis preserved action are both unique to that
individual
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11.10-Controls for closed
system-
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Electronic signatures and handwritten signatures executed to electronic
records shall be linked to their respective electronic records to ensure
that the signatures can not be excised, copied or otherwise transferred to
falsify and electronic record by ordinary means.
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11.100-General Requirements-
Unique
Verify the
identity
Certify
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Each electronic signature shall be unique to one individual and shall not
be reused by ,or reassigned to, anyone else.
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Before an organization establishes, assigns, certifies, or otherwise
individual’s electronic signature, or any element of such electronic
signature, the organization shall verify the identity of the individual.
At the time of joining that activity done by HR Department.
For vendor in service agreement need to be clarification.
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The certification shall be submitted in paper form and signed with a
traditional handwritten signature, to the Office of Regional Operations
Persons using electronic signatures shall, upon agency request, provide
additional certification that a specific electronic signature is the legally
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•Non biometric
1.
•Biometric
2.
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Electronic signature that are not based upon biometric
shall:
Employ at leas two distinct identification components such as a
t n
identification code and password
When an individual executes a series of signing during a single , continuous
period of controlled system access, the first signing shall be executed using
at least one electronic signature that used only by ,the individual.
Be used only by their genuine owners; and
Be administered and executed to ensure that used of an individual’s
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Persons who use electronic signatures based upon use of identification
code in combination with passwords shall employ control to ensure their
security and integrity. Such controls shall include:
Uniqueness
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Maintaining the uniqueness of each combined identification code and
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Ensuring that identification code and password issuances are
periodically checked ,recalled ,or revise (e.g., to cover such events as
password aging)
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Initial and periodic testing of devices, such as tokens or cards,
that bear or generate identification code or password
information to ensure that they function properly and have not
been altered in an unauthorized manner.
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Remember 21 CFR Part 11 is both technical and procedural
Always develop clear rationale as to how you are meeting all of the
requirement
Remember ,you are always responsible as end user so make sure you
do proper due diligence
Clearly identify what you consider to be electronic records
Make sure everyone in the organization understand electronic records
and electronic signatures
Perform regular follow up assessment to evaluate ongoing compliance
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https://en.wikipedia.org/wiki/Title21 of the Code of Federal
Regulations
CFR-Code of Federal Regulations Title 21.Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfcfr/c
frsearch.cfm
CFR-2018-TITLE21-VOL1-PART11
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