If any of the following hold true, then yes.
The FDA identified the following records as being applicable to Part 11:
- Records required for clinical investigations of medical products that are maintained in electronic format in place of paper format, including all records that are necessary for FDA to reconstruct a study.
- Records required for clinical investigations of medical products that are maintained in electronic format and where the electronic record is relied on to perform regulated activities.
- Records for clinical investigations submitted to FDA in electronic format under predicate rules, even if such records are not specifically identified in FDA regulations (see 122 § 11.1(b)).
- Electronic signatures required for clinical investigations intended to be the equivalent of handwritten signatures, initials, and other general signings.
For example, an investigator must maintain records of drug disposition and case histories for any individual that receives the investigational product. If your site keeps an electronic version of those disposition logs and case histories, then Part 11 applies to you. Part 11 applies to you regardless of whether you’re using an in-house system or a vendor system.