FileHold and FDA 21 CFR Part 11 Compliance

The Food and Drug Administration (FDA) 21 CFR Part 11 regulation defines the criteria under which electronic records and electronic signatures are considered to be a trustworthy equivalent to paper records. 21 CFR Part 11 provides guidelines and regulations related to copying, permissions, audit logs and tracking, version control, and the application of electronic signatures to electronic documents in the United States.

A new case study has been published that describes how one medical device company selected and validated a document management system for compliance with the United States Food and Drug Administration (US FDA) electronic record and electronic signature (21 CFR part 11) regulations. It describes how they went through the validation process using certain selection criteria to narrow down their selection. Compliance with the US FDA rules, cost, and usability were all factors in the selection process. Some systems were far too expensive for their needs. The usability of some systems were not right for their organization. Some required outside add-ons or had restrictions in terms of electronic signatures.

Out a total of 15 systems, FileHold was chosen as the winner as it met the needs for cost, usability and compliance. Once FileHold was chosen, it was then validated against the US FDA using a protocol that the medical device company defined. Validation activities included an informal vendor audit, defining the validation requirements, a review of the FileHold-supplied documentation and defining a specific process to support the validation. User training was combined with the validation process and the training was provided by FileHold. A traceability matrix was used to verify the US FDA requirements as well.

Once the validation was executed, FileHold was put into production. Some lessons that were learned during the validation process are described in the case study.

Read the full case study on one company's path to the US FDA 21 CFR Part 11 validation. You can also read an article on how FileHold software offers features that will help companies comply with 21 CRF Part 11. A complete compliance solution will include documented policies and procedures and a reliable secure IT infrastructure in addition to the FileHold document management software.