21 CFR

INTRODUCTION:

—  What is 21 CFR part 11?

v It’s a part of the code of federal regulations that establishes the united states Food and Drug Administration(FDA) regulations on Electronic and Electronic signatures(ERES).

WHAT IS THE PURPOSE OF 21 CFR PART 11?

It is essential for those FDA regulated companies that wish to use electronic quality records and electronic signatures in place of their paper-based and ink-based counterparts to comply with FDA regulations faster and more efficiently.

WHERE DOES 21 CFR PART 11 APPLY TO? 

§  It applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.

§  It applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA regulated industries.

BACKGROUND

—  In March 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic signatures, electronic records, and hand written signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

—  They were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect public health.

SUBPART OF 21 CFR 11

—  SUB PART A- GENERAL PROVISION

1.    SCOPE

2.    IMPLEMENATATION

3.    DEFINITIONS

•        SUBPART B- ELECTRONIC RECORDS

•        SUBPART C- ELECTRONIC SIGNATURES

SUBPART A – GENERAL PROVISION

• 1.    SCOPE:-

—  Electronic records to be trustworthy, reliable, and generally equivalent to paper records.

—  Electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings…

—  Electronic records may be use in lieu of paper records.

• 2 .    IMPLEMENTATION

§  For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records

§  Electronic signatures in lieu of traditional signatures. In whole or in part, provided that the requirements of this part be met.

§  The document or parts of a document to be submitted have been identified in public docket N0:- 92S- 0251 as being the type of submission the agency accepts in electronic form.

• 3.    DEFINITIONS

—  The definitions and interpretations of terms contained in section 201 of the act apply to those who used in this part.

1.    ACT:- means the federal food, drug and cosmetic act

2.    AGENCY:-  the food and drug administration

3.    BIOMETRICS: - method of verifying an individual’s identity.

4.    CLOSED SYSTEM: - An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

5.    .DIGITAL SIGNATURE: - an electronic signature based upon cryptographic methods of originator authentication.

6.    ELECTRONIC RECORDS:- any combination of text, graphics, data, pictorial, audio Representation in digital form

7.    HANDWRITTEN SIGNATURE: - The scripted name or legal mark of an individual. The act of signing with a writing or marking instrument such as pen or stylus is preserved.

8.    OPEN SYSTEM:- system access is not controlled by persons who are responsible for the content of electronic records that are on the system

• 4.    Subpart B ( ELECTRONIC RECORDS) 

—  CONTROL FOR CLOSED SYSTEM:-

—  Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate ( reject )the signed record as not genuine. Such procedures and controls shall include the following:

(a)  Validation of systems

(b) Accurate and complete copies

(c)  Protection of records by ready retrieval

(d) Limiting  system  access

(e)  Audit trials

(f)   Operational system checks

(g) Authority checks

(h) Device checks

(i)   Education, training and experience

(j)   Written policies

(k) Documentation

—CONTROL FOR OPEN SYSTEM

—  Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in CFCS, as appropriate and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.

—  3.Signature  manifestations : Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

—  (a) The printed name of the signer;

—  (b) The date and time when the signature was executed; and

—  (c) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

—  4. Signature / Record Linking: Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

• 5.     SUBPART C ( ELECTRONIC SIGNATURES)

—  1.General requirements :

—  (a)Unique

—  (b)Verify the identity

—  (c) Certify

—  2. Electronic signature components and controls :

—  (a)Non biometric

—  (b)Biometric

—  3. Controls for identification codes / passwords:

(a)  Uniqueness

(b) Code and passwords periodically checked

(c)  Loss management

(d) Safeguard to prevent unauthorized access

(e)  Periodic testing of devices

APPLICATIONS

—  To maintain proper records

—  To prevent wasting of critical resources

—  To maintain the software system in private and secure manner

—  Use of operating system checks

—  Use of authority checks

PRESENT UPDATE OF 21 CFR PART 11

FDA’S update 0f June 3 2020

—  FDA’s update of June 3, 2020 added guidance addressing:

—  Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records. FDA reiterates that electronic systems used to generate electronic signatures on clinical trial records, including informed consent documents, must comply with 21 CFR Part 11 (“Part 11”) when applicable. When an electronic system that is Part 11 compliant is not available, regulated entities must obtain required signatures by alternate means (e.g., handwritten wet ink signatures executed on documents, handwritten stylus or finger-drawn signatures executed on electronic documents that are then printed or appropriately witnessed)

-by Mounica Grace &  Priyanka Sharma.