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

Technical Specification Sheet

Document No. A6V11273349

March 2021

Siemens Industry, Inc.

Page 1 of 5

The APOGEE Compliance Solution with

Desigo CC— Technological Elements for 21

CFR Part 11 Compliance

Background

The U.S. FDA’s 21 CFR Part 11 was developed to

allow the widest possible use of electronic technology

in support of electronic record and electronic signature

systems. While the use of electronic records is

voluntary, an industry trend to move to paperless

records is driven by the efficiencies of electronic media

and the increased reliability and data integrity potential

of electronic systems over manual processes. The rule

was first issued in the spring of 1997. In 1998, the

Building Technologies Division of Siemens Industry,

Inc. delivered the first APOGEE

Compliance Solution

designed to address compliance needs. The APOGEE

Compliance Solution continues to evolve and with

each revision, provides users increased operational

efficiency as well as a reduction in risk.

The APOGEE Compliance Solution is a combination of

technological and procedural elements designed to

ensure full compliance with 21 CFR Part 11 (see

Figure 1), while minimizing the risk of failure.

The procedural elements include system validation,

training, standard operating procedures, and migration

planning performed by the system installer.

The technology portion of the solution includes the

combined features of Desigo

CC software and field

panel firmware. The technological elements necessary

to meet the requirements include record security,

record retention, audit trails, system security and

system/device checks.

The guiding principle of the compliance solution

strategy is to increase efficiency and reduce risk by

using the most effective mix of services and

technologies available at any point in time.

Figure 1. The APOGEE Compliance Solution.

Electronic Records

The term electronic records can be applied to data

from many types of systems and applications. Within

the APOGEE Automation System, there are six types

of records generated by the system that can be critical

to compliance.

▪ Trended Value Records

▪ Alarm Records

▪ System Activity Log Records (Audit Trails)

▪ System Configuration Parameters

▪ Custom Programs

▪ System Graphics

The APOGEE Compliance Solution addresses each

record throughout its lifecycle, including the point of

creation, transfer through the APOGEE Automation

System to long-term lifecycle management and

archiving. The compliance solution consists of a series

of components and procedures working together. The

absence of any one of these significantly increases the

risk of non-compliance.

Summary of content (5 pages)

PAGE 1
Technical Specification Sheet Document No. A6V11273349 March 2021 The APOGEE Compliance Solution with Desigo CC— Technological Elements for 21 CFR Part 11 Compliance Background The U.S. FDA’s 21 CFR Part 11 was developed to allow the widest possible use of electronic technology in support of electronic record and electronic signature systems.
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Electronic and Digital Signatures Electronic Signatures refer to the digital representation of a signature that is used to authorize or “sign” electronic reports. This functionality is reserved for electronic authorization of compliance level reporting. Digital Signatures, which often refer to the use of such things as User ID/password to track changes or provide access to system functions, are used throughout the APOGEE Compliance Solution, but should not be confused with electronic signatures.
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21 CFR Part 11 Designed Features • The key features of the Desigo CC solution that are designed to support 21 CFR Part 11 compliance include: • Management of Electronic Records – Desigo CC software provides long-term management and reporting of key electronic records. These include trend records, alarm records, system activity records, and Assisted Treatment operating procedure records.
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Datamate Advanced Datamate Advanced software is a powerful configuration tool that can be used to make changes locally at the APOGEE Field Panel. The following information is recorded in the System Activity Log within the Datamate software when a Supervised Object is modified or deleted: − Property – Describes what part of a supervised object was changed.
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Ordering Information Description Part Number Add 100 Validated Objects Add 500 Validated Objects Add 5000 Validated Objects Add 10000 Validated Objects Add 30000 Validated Objects Add 100000 Validated Objects Validated object licenses cannot be added to the Compact Validated System Package. P55802-Y154-A412 P55802-Y154-A452 P55802-Y154-A453 P55802-Y154-A414 P55802-Y154-A434 P55802-Y154-A415 Information in this document is based on specifications believed correct at the time of publication.