Data Sheet for Product

ManualsBrandsSiemens ManualsBuilding automationDesigo CC MP 5.0 BACnet Server, BACnet Protocol Implementation Conformance Statement (PICS), Basic Documentation

Regulated Facility Solution Set Matrix

Regulated Facility

Firmware

Desigo CC Software

Datamate Advanced Software

Network

Data Integrity

Data integrity for the APOGEE Automation System is verified through system validation. This ensures that the APOGEE Automation System meets an organization’s user requirements and any applicable regulatory requirements. Siemens has developed standard specifications and system verification

templates 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 “Validated state” throughout its lifetime, a comprehensive service

offering can be established.

Protection of Records

11.10 (b), 11.10 (c)

Password security and physical security must be enabled at the

field panels. It is recommended that a binary door monitoring

switch be added to each field panel used to collect information,

and that local access capability be disabled.

It is recommended that power be sourced from an

uninterrupted power supply (UPS), and the UPS is sourced

from emergency power grid. This practice eliminates loss of

data due to power blackouts, brownouts, surges, or dips.

Desigo CC software retains complete copies of system records in both human readable and

electronic form, available for inspection, review and copying.

It is recommended that power be sourced from an uninterrupted power supply (UPS) and the

UPS is sourced from emergency power grid. This practice eliminates loss of data due to

power blackouts, brownouts, surges, or dips.

Install robust server designs with built-in redundancy to protect data stored on the server hard

disk. Execute SOPs that regularly back up critical electronic records.

Access to the system is controlled using Windows integrated security. Users do not have to

manage a unique set of usernames and passwords. Using an individual’s domain account

name and password, the system can detect user access and will grant them access to only

those functions they are authorized to use. This access control is used to determine what

functions a user can use, what they can see, print, or otherwise have access to.

Datamate Advanced software retains complete copies of system records in both

human readable and electronic form, available for inspection, review and copying.

Access to the system is controlled using Windows integrated security. It is

recommended that access capability be limited to selected individuals and their

supervisor.

Desigo CC server is synchronized with Network

Time.

All components with time functions in the

APOGEE Automation System are automatically

synchronized to the system server daily.

Redundancy of network components is

recommended to ensure protection of records.

Trend

It is necessary to collect Trend Data from field panels as often

as possible to mitigate and/or significantly reduce possible loss

of data stored in panel RAM. This design consideration must

be considered in detail in specifications and validated.

The ability to change Trend Definitions is restricted by Desigo CC Access and Privileges. It

is recommended that access capability be limited to selected individuals and their supervisor.

The ability to change Trend Definitions is restricted by Datamate Advanced Access

and Privileges. It is recommended that access capability be limited to selected

individuals and their supervisor.

The ability to change Alarm parameters in Point Definitions is restricted by Access

and Privileges. It is recommended that access capability be to selected individuals

and their supervisor.

Records of changes made using Datamate Advanced software must be printed

periodically for secure, long-term storage. Records can be printed to paper or saved

as PDF files.

Not Applicable

Alarms

Alarm configuration is part of the Point Definition database.

System alarm records are automatically managed by the Desigo CC application. The ability

to change Alarm parameters in Point Definitions is restricted by access and privileges. It is

recommended that access capability be limited to selected individuals and their supervisor.

System Activity

At the field panel, local system access is not recommended.

All system changes should be made using Desigo CC software

to ensure a complete audit trail of all changes.

Desigo CC software will acquire records as they are created, lock them down in a secure

database, provide the ability to retain them for a user definable and/or indefinite time and

provide modern reporting functionality to visualize the data.

Point Definitions

The ability to change Point Definitions is restricted by ALN

Access and Privileges. It is recommended that access

capability be disabled.

The ability to change Point Definitions is restricted by Desigo CC Access and Privileges. It is

recommended that access capability be limited to selected individuals and their supervisor.

The ability to change Point Definitions is restricted by Datamate Advanced Access

and Privileges. It is recommended that access capability be limited to selected

individuals and their supervisor.

Not Applicable

PPCL

At the field panel, PPCL programs are stored in the EEPROM

memory and protected from data loss by battery within the

field panel. The ability to change PPCL programs is restricted

by ALN Access and Privileges. It is recommended that access

capability be disabled.

The ability to change PPCL is restricted by Access and Privileges. It is recommended that

access capability be limited to selected individuals and their supervisor. It is recommended

that PPCL modifications be accomplished through Desigo CC to ensure a complete audit trail

of changes.

The ability to change PPCL is restricted by Datamate Advanced Access and

Privileges. It is recommended that access capability be limited to selected

individuals and their supervisor.

Records of changes made using Datamate Advanced software must be printed

periodically for secure, long-term storage. Records can be printed to paper or saved

as PDF files.

Audit Trails

11.10 (e)

BACnet (Firmware) is an open communication protocol that

supports changes from devices external to the system. These

types of changes do not leave an audit trail. The BACnet

network must be secured procedurally to prevent users at

external devices from making changes.

Desigo CC software provides an automatic audit trail of any changes made to, Point

Definitions and other critical objects designated for enhanced audit trails. The Desigo CC

application captures and documents changes to APOGEE Automation System operations.

Desigo CC software will acquire records as they are created, lock them down in a secure

database, provide the ability to retain them for a user definable and/or indefinite time and

provide modern reporting functionality.

Desigo CC software manages system activity and operator transaction records.

Datamate Advanced software provides an audit trail of any changes made to PPCL,

Point Definitions and other critical point modifications executed via Datamate

Advanced.

Records of changes made using Datamate Advanced software must be printed

periodically for secure, long-term storage. Records can be printed to paper or saved

as PDF files.

Not Applicable

System Security

11.10 (d), 11.10 (f), 11.10 (g),

11.10 (h), 11.10 (j), 11.10 (k),

11.30

Password security and physical security must be enabled at the

field panels. It is recommended that a binary door monitoring

switch be added to each field panel used to collect information.

This demonstrates compliance with US FDA regulations, and

that the ALN system access is limited to a single individual

and their supervisor.

Systems that use Desigo CC flex client and click-once client must incorporate additional

security authentication measures, encryption mechanisms, firewall, and/or SSL (secure socket

layer) type technologies into building automation design.

Access to the system is controlled using Windows integrated security. Users do not have to

manage a unique set of usernames and passwords. Using domain accounts, the system can

detect an individual’s user access level and will grant them access to only those functions

they are authorized to use.

Access to the system is controlled using Windows integrated security. Users do not

have to manage a unique set of usernames and passwords. Using each individual’s

Windows account name and password, the system can detect user access and can

grant them access to only those functions they are authorized to use. This access

control is used to determine what functions a user can use, what they can view, print,

or otherwise have access.

Access rights to system records, reports, report

templates, and client applications are all

controlled using Windows integrated security.

Windows integrated security is designed and

configured properly to limit system access

through an SOP.

Electronic Signatures

11.50(a)(b), 11.70, 11.100,

11.200,11.300

Not Applicable

PDF based report output option can be combined

with Adobe’s or a third-party signature handler

and\ or a document management system.

Establish Procedures

11.10(j)

The 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,

Hardware Maintenance Procedures, Calibration Procedures, Software Maintenance Procedures, System Security Procedures, Training Procedures, Electronic Records/Data Management Procedures, Incident Management Procedures and Disaster Recovery Procedures.

Control Documents

11.10(k)

The 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

Specifications, Operations and Maintenance Manuals, Training Records, Calibration Records, System Drawings, Completed Protocol Documents, System Acceptance and Sign-off and Maintenance Records.