MeRITS implements new storage system for regulatory files
The Division of Regulated Activities and Compliance recently accepted delivery of a new web-based software application from the Medical Research Information Technology System Project Management Office that will be used to store the Department of the Army, Office of The Surgeon General sponsored regulatory files. The system is called the Sponsor's Electronic Regulatory Files, otherwise referred to as SERF.
"SERF is designed to be compliant with the Food and Drug Administration regulations for computer systems," said Dr. Robert Miller, Division of Regulated Activities and Compliance director. "This is one of the systems that is required before the USAMRMC moves from a paper based document management system to an FDA compliant one."SERF is a new addition to the MeRITS Electronic Document Management System, a web-based, commercial-off-the-shelf instance of LivelinkT that is configured to meet the functional requirements of the U.S. Army Medical Research and Materiel Command. The system was developed and tested by a working group composed of members of DRAC management, the DRAC Regulatory Submissions Team, and the MeRITS PMO.
EDMS provides SERF users with many useful features, including version control, audit trails, powerful search functions and integration with key desktop applications.
"Typically, members of integrated product teams and collaborators may need to have read access to files for particular investigational new drugs," said Maj. Lee Lefkowitz, MeRITS liaison officer.
SERF is a distinct, access-controlled area of EDMS designed to replace the U.S. Army Medical Materiel Development Activity's legacy FDA regulation 21CFR part 11 noncompliant Document Management System. SERF stores files and critical metadata to meet DRAC business requirements, as well as storing files that have been submitted to the FDA.
Files are uploaded to SERF by a member of the Regulatory Submissions team, and are categorized by product number and submission type to allow for easy and rapid retrieval. DRAC-appointed system administrators control the level of access to files on a case-by-case basis, allowing read-only access or granting permission for users to modify SERF content of restricting files.
Two training courses for SERF, EDMS-302 SERF User Training and EDMS-303 SERF Administrator Training, have been developed by the MeRITS PMO.