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Validation

Online Business Applications can help minimize the effort and frustration around Validation. Online Business Applications can assist with configuring the documents to specifically meet the client’s needs. We can customize the documents to ensure they will meet FDA as well as internal QA requirements.

Why use OBA for Validation?

Online Business Applications offers different levels of Validation Package to meet Client’s business needs.

Pre-Defined Validation Package

OBA’s standard predefined package is written in a way to meet any system configuration. This package allows companies to customize the document if necessary and do internal validation.

• Installation Qualification (IQP)-Standardized document which verifies and provides evidence that the installation has been performed completely and correctly. The IQ protocol will verify and document the IRMS software installation.
• Test Scripts (TS)-Standardized documents containing step-by-step procedures that test the functionality of the IRMS application.

Custom Validation Package

This package allows companies to meet internal validation requirements without the burden of customizing the document.

• User Requirements Specification (URS)-This customized document defines and lists features required in the IRMS application, to meet the client’s business requirements.
• Installation Qualification Protocol (IQP)-Customized document which verifies and provides evidence that the installation has been performed completely and correctly. The IQ protocol will verify and document the IRMS software installation.
• Test Scripts (TS)-Customized documents containing step-by-step procedures that test the functionality of the IRMS application.
• Requirement Traceability Matrix (RTM)-Customized document showing a comprehensive mapping of the user requirements and test scripts to IRMS and to the various test protocols that challenge each requirement.

Full Validation Package

OBA is responsible for complete validation from planning to final summary report. The end result is a fully validated and complaint Medical Information System without burdening the internal QA department.

• Validation Plan-Customized document outlines the processes for validating the IRMS application.
• User Requirements Specification (URS)-Customized document defines and lists features required in the IRMS application to meet the client’s business requirements.
• Functional Specification Documents (FSD)-While the User Requirements define the need in terms of business requirements, this document defines how the user requirements will be satisfied by IRMS. The User Requirements will be expanded in the FSD to further define how the system will meet each requirement.
• Requirement Traceability Matrix (RTM)-Customized document shows a comprehensive mapping of the user and functional requirements to IRMS and to the various test protocols that challenge each requirement.
• Installation Qualification Protocol (IQP)-Customized document verifies and provides evidence that the installation has been performed completely and correctly. The IQ protocol will verify and document the system hardware and software installation.
• Installation Qualification Report (IQR)-This report summarizes the results of the IQ and makes a recommendation to proceed to the next phase.
• Operational Qualification Protocol (OQP) -This document describes the process of establishing confidence that IRMS and all sub-systems are capable of consistently operating in accordance with requirements throughout all anticipated operational ranges. The OQ verifies that the system operates to its intended use in a test environment and meets defined requirements.
• Operational Qualification Report (OQR)-This report summarizes the results of the OQ and makes a recommendation to proceed to the next phase.
• Performance Qualification Protocol (PQP)-This document provides documented verification that the computerized system performs as intended in the production environment, throughout all the anticipated operating ranges. The PQ includes an evaluation of the ability of users of the system to understand and correctly interface with it. Operators should be able to perform the intended functions.
• Performance Qualification Report (PQR)-This report summarizes the results of the PQ and makes a recommendation to proceed to the next phase.
• Validation Summary Report-This report reviews all of the activities performed under the Validation Plan and summarizes the validation effort. Both problems and successes are discussed and an overall assessment of the System’s suitability for its intended use is stated.