Validation and Compliance with CFR 21 PART 11

When does the regulation apply?

Page I of III

What is 21 CFR Part 11?

21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

Does 21 CFR Part 11 apply to me?
The first step in becoming compliant with the regulations is to determine whether or not you are required to be compliant. The following questions can help lead to the determination:

  1. Is your clinical trial conducted under an approved IND?
  2. Is your clinical trial conducted under an approved IDE?
  3. Does your grant specify that your computer systems must comply with 21 CFR Part 11 or similar requirements?

If you answered yes to any of these questions, your electronic systems of record that are being used to meet predicate rules are required to comply with 21 CFR Part 11.

The second step of the process is to identify the computer systems you are using in your clinical trial.

Addressing the following can help identify all of the computer systems associated with your trial:

  1. Are you using an outside laboratory for laboratory analysis?
    If so, is the laboratory accredited?

    -If the laboratory is not accredited, assurance should be required in regard to the data quality
  2. Are you using a laboratory within UT-Houston for analysis?
    - If yes, the instruments being used should be compliant
  3. Are you entering data directly into an electronic database?
    - If yes, the database must be compliant
  4. Are you entering data (from paper) into an electronic database?
    - If yes, then the database must be compliant (as discussed in the Scope of Guidance for Industry: Computerized Systems Used in Clinical Trials)
  5. Are you using electronic logs?
    - If yes, then the logs must be compliant

Page II: Click here to find out what software features are necessary to be 21 CFR Part 11 compliant

Page III: Click here to see an example process of system validation

Please Note: Not validating your electronic system(s) of record may result in regulatory citations. If you have any questions or concerns about your system, it is highly recommended that you contact the CTRC for guidance



Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334

last modified October, 2013
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