Understanding FDA's 21 CFR Part 11 Requirements Quiz

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.

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.