IRMS Validation
The Information Request Management System (IRMS) has grown into the most widely used Medical Information solution available today. Utilized in more than 50 pharmaceutical and biotech companies, IRMS has been widely adapted to more than just medical information.
Many medical information departments in the Pharmaceutical and Biotech industries either completely handle, or at least initially accept potential adverse events or product complaints. IRMS therefore must adhere to the FDA's 21 CFR Part 11. This regulation is a means of ensuring that electronic systems will record, store and report data correctly.
While 21 CFR Part 11 has a number of technical requirements that IRMS has been developed to meet, including strict password requirements, audit trails and more, it also means validation.
Validation, in the simplest terms, generally means documenting what a system is suppose to do, then testing and documenting that it does exactly that. There is a library of documents required for a successful validation that must be completed. The task can seem daunting with the need to complete a Validation Plan, User Requirements, Functional Specification, Installation Qualification (IQ), Performance Qualification (PQ), Operational Qualification (OQ), Traceability Matrix etc. Departments can easily be overwhelmed.
Online Business Applications can help minimize the effort and frustration around validation since IRMS is already developed to meet 21 CFR Part 11 requirements. IRMS maintains detailed audit trails of records, has strict user password requirements, incorporates electronic signatures and other requirements of the regulation.
IRMS is also an off-the-shelf software package, which means we keep all of our documentation up to date with the latest release. We have all of the necessary documentation prepared and ready to go. Online Business Applications can assist with configuring the documents to specifically meet the use of the client, and we can customize the validation documents to ensure they will meet FDA as well as internal QA requirements. In addition, we will execute the appropriate test scripts after installation, configuration, and before go-live to complete the IQ, OQ and PQ.
The end result is a fully validated and compliant Medical Information system.
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