Bundled solution helps facilities meet 21 CFR 11 regulations

Bundled solution for building automation systems is designed to help FDA-regulated industries meet 21 CFR Part 11 requirements to store signatures and records electronically.

02/19/2004



Bundled solution for building automation systems is designed to help FDA-regulated industries meet 21 CFR Part 11 requirements to store signatures and records electronically. From Siemens Building Technologies, Inc. , the package includes the company’s Apogee Building Automation System to address technological elements of Part 11 compliance, plus a comprehensive series of Apogee building automation services that focus on the procedural elements of compliance. All components can be tailored to specific requirements and requests.



Technological elements in the solution include automated audit trails, electronic signatures, and data security. Procedural elements include Part 11 gap analysis, compliance remediation and ongoing consultation. A dedicated Part 11 compliance team oversees the development of ongoing compliance efforts and guides and supports the field organization in the application of the Part 11 solution. This solution also meets the facility requirements of 21 CFR Parts 210 and 211 (current good manufacturing practices).

21 CFR Part 11 was introduced in the 1990s in response to pharmaceutical company requests for guidelines on submitting and storing data electronically. Part 11 establishes criteria under which the FDA considers electronic records and signatures reliable and equivalent to paper records and handwritten signatures.

—Jeanine Katzel, Senior Editor, Control Engineering, jkatzel@reedbusiness.com





The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by Control Engineering subscribers. Vote now (if qualified)!
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
HMI effectiveness; Distributed I/O; Engineers' Choice Award finalists; System Integrator advice; Inside Machines
Women in engineering; Engineering Leaders Under 40; PID benefits and drawbacks; Ladder logic; Cloud computing
Robotic integration and cloud connections; SCADA and cybersecurity; Motor efficiency standards; Open- and closed-loop control; Augmented reality
Programmable logic controllers (PLCs) represent the logic (decision) part of the control loop of sense, decide, and actuate. As we know, PLCs aren’t the only option for making decisions in a control loop, but they are likely why you’re here.
This digital report explains how motion control advances and solutions can help with machine control, automated control on assembly lines, integration of robotics and automation, and machine safety.
This article collection contains several articles on how advancements in vision system designs, computing power, algorithms, optics, and communications are making machine vision more cost effective than ever before.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

Control room technology innovation; Practical approaches to corrosion protection; Pipeline regulator revises quality programs
Cloud, mobility, and remote operations; SCADA and contextual mobility; Custom UPS empowering a secure pipeline
Infrastructure for natural gas expansion; Artificial lift methods; Disruptive technology and fugitive gas emissions
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by Control Engineering subscribers. Vote now (if qualified)!
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
HMI effectiveness; Distributed I/O; Engineers' Choice Award finalists; System Integrator advice; Inside Machines
Women in engineering; Engineering Leaders Under 40; PID benefits and drawbacks; Ladder logic; Cloud computing
Robotic integration and cloud connections; SCADA and cybersecurity; Motor efficiency standards; Open- and closed-loop control; Augmented reality
Programmable logic controllers (PLCs) represent the logic (decision) part of the control loop of sense, decide, and actuate. As we know, PLCs aren’t the only option for making decisions in a control loop, but they are likely why you’re here.
This digital report explains how motion control advances and solutions can help with machine control, automated control on assembly lines, integration of robotics and automation, and machine safety.
This article collection contains several articles on how advancements in vision system designs, computing power, algorithms, optics, and communications are making machine vision more cost effective than ever before.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

Control room technology innovation; Practical approaches to corrosion protection; Pipeline regulator revises quality programs
Cloud, mobility, and remote operations; SCADA and contextual mobility; Custom UPS empowering a secure pipeline
Infrastructure for natural gas expansion; Artificial lift methods; Disruptive technology and fugitive gas emissions
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by Control Engineering subscribers. Vote now (if qualified)!
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
This eGuide illustrates solutions, applications and benefits of machine vision systems.
Learn how to increase device reliability in harsh environments and decrease unplanned system downtime.
This eGuide contains a series of articles and videos that considers theoretical and practical; immediate needs and a look into the future.
HMI effectiveness; Distributed I/O; Engineers' Choice Award finalists; System Integrator advice; Inside Machines
Women in engineering; Engineering Leaders Under 40; PID benefits and drawbacks; Ladder logic; Cloud computing
Robotic integration and cloud connections; SCADA and cybersecurity; Motor efficiency standards; Open- and closed-loop control; Augmented reality
Programmable logic controllers (PLCs) represent the logic (decision) part of the control loop of sense, decide, and actuate. As we know, PLCs aren’t the only option for making decisions in a control loop, but they are likely why you’re here.
This digital report explains how motion control advances and solutions can help with machine control, automated control on assembly lines, integration of robotics and automation, and machine safety.
This article collection contains several articles on how advancements in vision system designs, computing power, algorithms, optics, and communications are making machine vision more cost effective than ever before.

Find and connect with the most suitable service provider for your unique application. Start searching the Global System Integrator Database Now!

Control room technology innovation; Practical approaches to corrosion protection; Pipeline regulator revises quality programs
Cloud, mobility, and remote operations; SCADA and contextual mobility; Custom UPS empowering a secure pipeline
Infrastructure for natural gas expansion; Artificial lift methods; Disruptive technology and fugitive gas emissions
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
click me