Siemens Regulated Facility Solution Set Matrix

Regulated Facility Integrity of Records b 11.10 c integrity for the APOGEE Automation System is verified through system validation This ensures that the APOGEE Automation System meets an organization user requirements and any applicable regulatory requirements Siemens has developed standard specifications and system verification to aid an organization in the validation of the APOGEE Automation System Templates based on current industry practices save time and money on the project To ensure the APOGEE Automation System is maintained in a state throughout its lifetime a comprehensive service can be established security and physical security must be enabled at the panels It is recommended that a binary door monitoring be added to each field panel used to collect information that local access capability be disabled Advanced software retains complete copies of system records in both readable and electronic form available for inspection review and copying CC server is synchronized with Network CC software retains complete copies of system records in both human readable and form available for inspection review and copying is recommended that power be sourced from an uninterrupted power supply UPS and the is sourced from emergency power grid This practice eliminates loss of data due to blackouts brownouts surges or dips to the system is controlled using Windows integrated security It is that access capability be limited to selected individuals and their Advanced Software Facility Solution Set Matrix CC Software is recommended that power be sourced from an power supply UPS and the UPS is sourced emergency power grid This practice eliminates loss of due to power blackouts brownouts surges or dips is necessary to collect Trend Data from field panels as often possible to mitigate and or significantly reduce possible loss data stored in panel RAM This design consideration must considered in detail in specifications and validated configuration is part of the Point Definition database Activity At the field panel local system access is not recommended system changes should be made using Desigo CC software ensure a complete audit trail of all changes Definitions The ability to change Point Definitions is restricted by ALN and Privileges It is recommended that access be disabled robust server designs with built in redundancy to protect data stored on the server hard Execute SOPs that regularly back up critical electronic records to the system is controlled using Windows integrated security Users do not have to a unique set of usernames and passwords Using an individual domain account and password the system can detect user access and will grant them access to only functions they are authorized to use This access control is used to determine what a user can use what they can see print or otherwise have access to ability to change Trend Definitions is restricted by Desigo CC Access and Privileges It recommended that access capability be limited to selected individuals and their supervisor alarm records are automatically managed by the Desigo CC application The ability change Alarm parameters in Point Definitions is restricted by access and privileges It is that access capability be limited to selected individuals and their supervisor CC software will acquire records as they are created lock them down in a secure provide the ability to retain them for a user definable and or indefinite time and modern reporting functionality to visualize the data ability to change Point Definitions is restricted by Desigo CC Access and Privileges It is that access capability be limited to selected individuals and their supervisor At the field panel PPCL programs are stored in the EEPROM and protected from data loss by battery within the panel The ability to change PPCL programs is restricted ALN Access and Privileges It is recommended that access be disabled ability to change PPCL is restricted by Access and Privileges It is recommended that capability be limited to selected individuals and their supervisor It is recommended PPCL modifications be accomplished through Desigo CC to ensure a complete audit trail changes Trails e Firmware is an open communication protocol that changes from devices external to the system These of changes do not leave an audit trail The BACnet must be secured procedurally to prevent users at devices from making changes Security d 11.10 f 11.10 g h 11.10 j 11.10 k security and physical security must be enabled at the panels It is recommended that a binary door monitoring be added to each field panel used to collect information demonstrates compliance with US FDA regulations and the ALN system access is limited to a single individual their supervisor CC software provides an automatic audit trail of any changes made to Point and other critical objects designated for enhanced audit trails The Desigo CC captures and documents changes to APOGEE Automation System operations CC software will acquire records as they are created lock them down in a secure provide the ability to retain them for a user definable and or indefinite time and modern reporting functionality CC software manages system activity and operator transaction records that use Desigo CC flex client and click once client must incorporate additional authentication measures encryption mechanisms firewall and or SSL secure socket type technologies into building automation design to the system is controlled using Windows integrated security Users do not have to a unique set of usernames and passwords Using domain accounts the system can an individual user access level and will grant them access to only those functions are authorized to use Applicable components with time functions in the Automation System are automatically to the system server daily of network components is to ensure protection of records Applicable ability to change Trend Definitions is restricted by Datamate Advanced Access Privileges It is recommended that access capability be limited to selected and their supervisor ability to change Alarm parameters in Point Definitions is restricted by Access Privileges It is recommended that access capability be to selected individuals their supervisor of changes made using Datamate Advanced software must be printed for secure long term storage Records can be printed to paper or saved PDF files ability to change Point Definitions is restricted by Datamate Advanced Access Privileges It is recommended that access capability be limited to selected and their supervisor ability to change PPCL is restricted by Datamate Advanced Access and It is recommended that access capability be limited to selected and their supervisor of changes made using Datamate Advanced software must be printed for secure long term storage Records can be printed to paper or saved PDF files Advanced software provides an audit trail of any changes made to PPCL Definitions and other critical point modifications executed via Datamate of changes made using Datamate Advanced software must be printed for secure long term storage Records can be printed to paper or saved PDF files Applicable Applicable Signatures Applicable 11.70 11.100 Procedures Siemens 2012 2021 All rights reserved customer must develop their own Standard Operating Procedures SOPs for the proper use and operation of the BAS Siemens recommends that the following SOPs be developed for a customer site System Operating Procedures Backup Procedures Change Control Upgrade Procedures Maintenance Procedures Calibration Procedures Software Maintenance Procedures System Security Procedures Trainin g Procedures Electronic Records Data Management Procedures Incident Management Procedures and Disaster Recovery Procedures Documents customer must have the required documentation available and protected Revision and change control procedures should be in place for all the required documentation The list of the required documentation includes but is not limited to User Requirements Functional Specification Configuration Operations and Maintenance Manuals Training Records Calibration Records System Drawings Completed Protocol Documents System Accepta