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.

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 sytems 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
   

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

Part 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.