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