21 CFR part 11

21 CFR is reserved for rules of the FOOD and DRUG ADMINISTRATION (FDA)
It is divided into 3 Chapters
Chapter 1 – Food and Drug Administration
Chapter 2 – Drug Enforcement Administration
Chapter 3 – Office of National Drug Control Policy
Part 11 falls under chapter 1
It establishes the US FDA regulations on Electronic Records and Electronic Signature
It defines the criteria under which Electronic records and Electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
21 CFR part 11 is further divided into 3 subparts
Subpart A – General Provisions
Subpart B – Electronic Records
Subpart C – Electronic Signature

1. Welcome Presentation on 21 CFR part 11 NAME:FAUZIYYA SHAHUL HAMEED QUALIFICATION:BDS STUDENT ID : CSRPL _INT_ONL_WKD_202/1222 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index CFR Overview 21 CFR part 11 basics Subpart A Subpart B Subpart C Summary 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. CFR Overview CFR is the codification of general and permanent rules published in the federal register by the executive departments and agencies of the Federal Government of the US. It is divided into 50 titles that represent broad areas subject to federal regulation Each title is updated once every year Title >Chapter >Subchapter >Part >Subpart 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 3

4. 21 CFR part 11 Basics 21 CFR is reserved for rules of the FOOD and DRUG ADMINISTRATION (FDA) It is divided into 3 Chapters Chapter 1 – Food and Drug Administration Chapter 2 – Drug Enforcement Administration Chapter 3 – Office of National Drug Control Policy Part 11 falls under chapter 1 It establishes the US FDA regulations on Electronic Records and Electronic Signature It defines the criteria under which Electronic records and Electronic signatures are considered trustworthy, reliable, and equivalent to paper records. 21 CFR part 11 is further divided into 3 subparts Subpart A – General Provisions Subpart B – Electronic Records Subpart C – Electronic Signature 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

5. Subpart A Subpart A – General Provisions Scope of regulations Implementation of regulations Definitions of key terms used in regulations Part 11 applies to all electronic records that fall under the FDA regulations The FDA will accept electronic submissions instead of paper if those submissions adhere to part 11 requirements and are included among the type of documents that the FDA accepts electronically 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Subpart B Subpart B – Electronic Records Controls for closed systems Controls for open systems Signature manifestations Signature and record linking 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. The closed system must have a collection of technological and procedural control to protect the data within the system Open system An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. The open system must have controls to ensure that all records are authentic, incorruptible, and confidential (where required) 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

7. Subpart B …. contd The documented procedures and controls must include Computer system validation Record rendering Document storage and record retention System access Audit trials Workflows Authority checks Device checks Personnel qualifications Personnel accountability and document control 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Subpart C Subpart C- Electronic signature General requirements Electronic signature components and controls Controls for identification codes and passwords Organisations who are planning to use electronic signatures must inform the FDA in advance. Each person using an Electronic signature must have their identity confirmed and use a unique signature that has never been and will never be used by another individual. There are specific design requirements for electronic signatures that are biometric and those that are nonbiometric. 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 8

9. Summary 21 CFR part 11 describes how a company operating in the US can use electronic quality records and digital signatures in place paper-based documentation and wet signatures in such a way that complies with FDA regulation 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 9

10. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 1/2/2023 www.clinosol.com | follow us on social media @clinosolresearch 10