21 CFR Part 11 Quiz: FDA Regulations and Interview Questions

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Questions and Answers

What is a key requirement for ensuring data integrity?

Sharing common User ID and password

Obscuring data with annotation tools

Using correction fluids on printed data

Consistent application of data time stamps (correct)

How should corrections be made according to Good Documentation Practices?

Writing over the incorrect data

Making corrections as per Good Documentation Practices (correct)

Using fade ink cartridges

Using erasers or pencils

What is the purpose of FDA's 21 CFR Part 11?

To facilitate the use of electronic records and signatures instead of paper records (correct)

To ensure that data is stored only in paper records

To require handwritten signatures on all records

To discourage the use of computers in data management

Which of the following is a requirement for closed systems under 21 CFR Part 11?

Training/qualification of personnel Signup and view all the answers

What should not be done to ensure data printouts are readable?

Applying correction fluids on printouts Signup and view all the answers

What type of systems fall under 21 CFR Part 11?

Closed and open systems Signup and view all the answers

Why is it important for data to be legible?

To have handwriting that is readable by others Signup and view all the answers

Which action compromises the security of electronic records?

Recording common User IDs and passwords Signup and view all the answers

What is NOT a purpose of 21 CFR Part 11?

To allow repudiation of approvals Signup and view all the answers

What is the risk of not attributing activities to specific individuals?

Not being able to identify the person responsible for activities or changes Signup and view all the answers

Which of the following is a best practice for maintaining data integrity?

Backing up validated spreadsheets Signup and view all the answers

What are some controls listed for closed systems under 21 CFR Part 11?

Electronic audit trail and limited system access Signup and view all the answers

What does Data Integrity refer to?

Ensuring data is complete, consistent, and accurate throughout the data lifecycle. Signup and view all the answers

What does the FDA's Application Integrity Policy aim to address?

Fraud and untrue statements of material facts in data integrity. Signup and view all the answers

What is a key requirement for handwritten entries based on the text?

Entries should be clear, legible, and indelible. Signup and view all the answers

When should records be made or completed according to best practices?

After each action is taken. Signup and view all the answers

What should be done when an alteration is made to a document based on the provided guidelines?

The alteration should be signed and dated, with the reason for the alteration recorded. Signup and view all the answers

What does GXP stand for in the context of Data Integrity?

Good Practices for Data Management and Integrity Signup and view all the answers

Study Notes

Data Integrity Requirements

Consistent application of data timestamps is essential in the expected sequence.
Data should be recorded on controlled worksheets, laboratory notebooks, or electronic media.
Data should be available and accessible for review/audit for the lifetime of the record.

21 CFR 211.194

Date and time stamps are necessary to record data for the lifetime of the record.
Record data should be attributable to the person who performed the activity.

Examples of Data Integrity Issues

Failure to use unique login credentials (e.g., using a common user ID and password).
Disabling audit trails makes it impossible to identify the person who performed the activity.
Failing to log out of computers (e.g., HPLC machine) allows subsequent analyses to be performed by another user under the same login.
Designing forms or records without space for recording observations or additional information.
Having one person perform an activity and another person sign for it.

Legibility and Good Documentation Practices

Handwriting should be readable by others.
Any corrections should be done according to Good Documentation Practices.
Data cannot be obscured with annotation tools.
Data printouts should be readable, and not smudged or faded.

Availability of Data

Data should not be hidden or deleted periodically (e.g., OOS results).
Files should be backed up regularly to prevent data loss.
Records should be archived until the end of their retention period.
Validated spreadsheets should be backed up.

21 CFR Part 11 Overview

21 CFR Part 11 allows the use of electronic records and signatures instead of paper records and handwritten signatures.
It applies to all FDA-regulated environments, especially when using computers for data creation, modification, archiving, retrieval, or transmission.
It applies to records required by predicate rules (GLP, GCP, GMP) that impact patient safety.

Purpose of 21 CFR Part 11

Ensure data is not corrupted or lost.
Ensure data is secure.
Ensure approvals cannot be repudiated.
Ensure changes to data can be traced.
Make attempts to falsify records difficult and detectable.

Types of Systems

Closed systems: controlled access, limited access to data.
Open systems: open access, no control over data access.

21 CFR Part 11 Requirements

Validation.
Device checks.
Operational system checks.
Accurate and complete copies.
Accurate and steady retrieval.
Limited access to systems and data.
Authority checks.
Electronic audit trail.
Training and qualification of personnel.
Accountability of signatures.
Control over system documentation.

Data Integrity Regulations

FDA September 1991: Application Integrity Policy.
FDA Guidance for Industry April 2016: Data Integrity and Compliance With CGMP.
MHRA Guidance March 2018: GXP Data Integrity Guidance and Definitions.
WHO Guidance September 2015: Good Data and Record Management Practices.
PIC/S Guidance November 2018: Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments.
EMA Questions & Answers August 2016: Data Integrity and Compliance With CGMP.

Data Integrity Definitions

Data Integrity is the extent to which all data are complete, consistent, and accurate throughout the data lifecycle.
Handwritten entries should be clear, legible, and indelible.
Records should be made or completed at the time each action is taken and should be traceable.
Any alteration made to an entry should be signed and dated, and permit the reading of the original information.

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Description

Test your knowledge of FDA's 21 CFR Part 11 requirements with this quiz. Learn about data storage, backup, archiving, and validation practices outlined in the regulation.