ולידציה - FRS for Compliance with 21 CFR Part 11
Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11
פורסם:
Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11 This FRS presents SmarLogic's functional requirements in response to the User Requirements Specification (URS) . These functional requirements should be met in order to ensure Control and Monitoring System complies with 21 CFR Part 11. This FRS must be considered for the system design, build, installation, operation and testing requirements, and for traceability purposes along the product life cycle up to the Operational Qualification ( OQ ) stage. Responsibility The Validation Engineer is responsible for writing this protocol. The Control, Automation & Validation Engineer is responsible for ensuring the preparation and approval of this protocol. The Control Engineer, Division Process Engineer and QA Manager are responsible of approving this document before development and on-site implementations. The following sections list the functional requirements determined by the relevant groups of the system upgrading. Each functional requirement number is followed by the corresponding user requirement paragraph number for design qualification purpose Glossary ER - Electronic Record DB - Database FRS - functional requirements Specification HMI - Human/Machine Interface HSP - High Set-Point HW - Hardware IQ - Installation Qualification LSP - Low Set-Point OQ - Operational Qualification OS - Operating System PLC ָָ*- Programmable Logic Controller QA - Quality Assurance SCR - Screen SOP - Standard Operating Procedures SP - Set-Point SSO - Schedule of System Operation SW - Software TP - Test Point URS - User Requirements Specification Requirements for Meeting 21 CFR Part 11 Top-Level Requirements This section covers the proposed solutions for meeting 21 CFR Part 11 presented in the URS for a new WinCC HMI System. This system must allow the : following five main functionalities Ensure the system integrity Control the access to the system by logical security Audit events that create and modify electronic records Apply electronic signatures to the system Backup and archive data to ensure record integrity in case of failure Detailed Requirements This section describes SmartLogic's solutions that will meet the detailed requirements listed in the URS. These requirements are divided into 6 categories for the sake of clarity: Electronic Records Security Audit Trail Archive Backup * Here are some examples of the PLCs used by smartlogic: 6XV1830-0EH10, 6ES7131-4BF00-0AA0,6ES7193-4CA40-0AA0,6ES7134-4GD00-0AB0,6ES7193-4CA40-0AA0, 6ES7138-4CA01-0AA0,6ES7193-4CC20-0AA0, 6ES7590-1AB60-0AA0, 6ES7511-1AK00-0AB0, 6ES7954-8LP01-0AA0,6ES7155-6AU00-0BN0