ולידציה - FRS - Regulatory & HMI Requirements
FRS - Regulatory Requirementscover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual valida…
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ולידציה - FRS - Regulatory & HMI Requirements This article was written by Iian Shaya, validation,automation and control expert Regulatory Requirements These requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands Method to provide a computerized system that complies with 21 CFR Part 11 definitions, such as the system access control by the user's managing personnel, who shall be responsible for the content of the electronic records (ERs) contained in the system Method to restrict logical access to the system according to specified authorization levels Method to restrict logical access to the system only to specific user ID and password Method to provide system capability to record the values, alarms, user changes and any other events, and provide readable forms and reports of ER data Method to allow storage of historical events, current alarms and historical alarms data records on the computerized system database Capability of data display to the user in "view only" mode, so the user cannot alter or delete data/records Provision of user's capability to backup data daily, weekly and monthly, according to his procedures, to ensure protection of the records and to enable their accurate and ready retrieval throughout the records retention period Provision by the supplier of a project plan and quality assurance ( QA ) processes during development and the testing stages as part of his QA systems Provision by the supplier of the following documents Functional Requirements Specification - FRS Functional Design Specification- FDS IO List Schedule of System Operation - SSO Installation Qualification ( IQ ) protocol Operation Qualification ( OQ ) protocol Performance Qualification (PQ) protocol HMI Requirements These requirements are intended to provide the URS demands from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer's contract with the supplier. The HMI screens provided usually are of the following types Main Screen Synoptic screens for displaying online values and status Parameters screens for displaying temperature, humidity and pressure parameters values Data logging and storage of historical trends, alarms and events Tabular screens for displaying alarms Graphical screens for displaying trends This article was written by Iian Shaya, validation,automation and control expert