FDA Releases Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
October 8, 2024
In October 2024, the U.S. Food and Drug Administration issued a final guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. https://www.fda.gov/media/166215/download
This guidance provides recommendations on the use of electronic systems, electronic records and electronic signatures in food, medical product, tobacco product, and new animal drug clinical investigations.
This guidance finalizes the draft guidance for industry issued in March 2023, titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11–Questions and Answers.
Flex Databases has analyzed the guidance and is ready to share how we support our Clients being the trusted software development vendor.
Regulated entities are responsible for ensuring that electronic records meet applicable part 11 requirements. When determining the suitability of the IT service and IT service provider, regulated entities should consider the following regarding the IT service provider’s ability to ensure the authenticity, integrity, and confidentiality of clinical investigation records and data:
| FDA requirement | Flex Databases guarantees |
| Processes and procedures the IT service provider has in place for validation of specific IT services to be used in the clinical investigation | Fully validated system with the validation deliverables package Support during User Acceptance Testing |
| Ability of the IT service provider to generate accurate and complete copies of records and to provide access to data for as long as the records are required to be retained by applicable regulations | Retention period is negotiated and captured in the contract. All the data stored in the system is subject to full backup and is stored as long as required. |
| Processes and procedures the IT service provider has for data migration, data backup, recovery, contingency plans, and retaining records and making them available for FDA inspection for as long as the records are required to be retained by applicable regulations | Always ready to share our SOPs, including the backup procedure, Disaster Recovery and Business Continuity Plans and Reports, data migration working practice and relevant deliverables |
| Ability to provide secure, computer-generated, time-stamped audit trails of users’ actions and changes to data | Audit trail captures all actions performed in the system |
| Ability to secure and protect the confidentiality of data at rest and in transit (as appropriate for the content and nature of the record) | All traffic into and out of the Flex Databases Platform is encrypted, all backups are encrypted-in-transit to the separate data center and are encrypted-at-rest while stored at that location. |
