For electronic systems owned or managed by sponsors and other regulated entities that fall under the scope of 21 CFR part 11, what will be the FDA’s focus during inspections?
A FDA inspection will focus on the implementation of the electronic system, any changes made to the system, and documentation of validation. The FDA will also focus on source data that are transferred to another data format to ensure checks are in place and that critical data are not altered during the migration process. Additionally, they will review SOPs and support mechanisms in place to ensure that the system is functioning and being used in the manner intended (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Under 21 CFR 11.10(d), what are the FDA’s expectations regarding the use of internal and external security safeguards?
Sponsors and other regulated entities must have process to safeguard the authenticity, integrity, and confidentiality of electronic records. There should be a procedure to limit access to their electronic system to authorized users and there should be external security safeguards to prevent, detect, and mitigate effects of computer viruses and other harmful software code (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Is the electronic document management system that we use for SOPs and SOP training records required to be 21 CFR part 11 compliant?
Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations, as well as electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Who has the responsibility for ensuring that the software is part 11 compliant when a company on behalf of the sponsor provides it?
If a non-US site is conducting a clinical investigation, are records required by FDA regulations subject to part 11 requirements?
If it is conducting a clinical investigation under an investigational new drug application, yes. Under an investigational device exemption, if the sites agree to comply with 21 CFR part 812, then yes as well. For foreign studies not conducted under an IND or an IDE, good clinical practice standard for electronic records and electronic systems would apply (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Is it acceptable to have consent form sent via email instead of fax to obtain consent from a LAR?
Would it ever be appropriate for a PI to approach a subject’s friend/family to obtain current contact information for a discontinued subject lost to follow up without having the subject’s prior consent to do so?
The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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