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Technical Specification Sheet

Document No. 149-202

September 7, 2012

Siemens Industry, Inc.

Page 1 of 5

The APOGEE Compliance Solution —

Technological Elements for 21 CFR Part 11

Compliance

Background

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

permit 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, providing users increased operational

efficiency while at the same time 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, while

minimizing the risk of failure. The cornerstones of this

solution are APOGEE Building Automation Services

and APOGEE Building Automation Technologies (see

Figure 1).

The APOGEE Building Automation Services are a

series of compliance-based services that are designed

to address the procedural elements that are key

components of any compliance solution. These include

system validation, training, standard operating

procedures and migration planning.

The APOGEE Building Automation Technologies

include the combined features of the workstation

software (Insight

software and the InfoCenter Suite

software) and field panel firmware that are required to

address technological elements such as record

security, record retention, audit trails, system security

and system/device checks.

Figure 1. The APOGEE Compliance Solution.

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.

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 five types

of records generated by the system that can be critical

to compliance. Figure 2 shows these five types of

records, along with the APOGEE Automation System

components that are required to manage these

records electronically within the APOGEE Compliance

Solution.

Summary of content (5 pages)

PAGE 1
Technical Specification Sheet Document No. 149-202 September 7, 2012 The APOGEE Compliance Solution — Technological Elements for 21 CFR Part 11 Compliance Background The U.S. FDA’s 21 CFR Part 11 was developed to permit the widest possible use of electronic technology in support of electronic record and electronic signature systems.
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• Supervised Objects: The following object types may be designated as Supervised; a point, trend definition, trend collection report, user account, or PPCL program. Modifications and deletions to a Supervised Object presents a warning that may require a user password and/or a supervisor password (user defined) in order to execute the modification or deletion.
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Insight Alarm Issue Management (AIM) Option The Alarm Issue Management Option for Insight provides a structured process to manage the life cycle of an alarm issue, from initiation to resolution. AIM enforces an ordered procedure that must be followed for each point in alarm. The individual steps are: Acknowledge, Assign (to a contact), Answer, Resolve, and Clear. Each step is logged through the AIM application and a full history of all actions for a given issue is recorded in the System Activity Log.
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Field Panel Firmware Compliance-based Features To ensure that records are protected at their point of creation and to reduce the need for procedurally based service modes, the field panel firmware has multiple technical elements to maximize compliance, including: • • BLN Operator Activity Logging – Firmware Revision 2.6 or later can be configured to track and upload detailed operator activity to the Insight System Activity Log application and can ultimately be transferred to the InfoCenter Suite solution.
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Ordering Information Description Part Number Compliance Support Option for Insight 571-126 Validation Options Bundle Includes both the Compliance Support Option and the Alarm Issue Management Option 571-125 InfoCenter Suite Advanced 571-390 Information in this document is based on specifications believed correct at the time of publication. The right is reserved to make changes as design improvements are introduced. APOGEE, Insight, and InfoCenter are registered trademarks of Siemens Industry, Inc.