Schneider, Stelex show how to comply with FDA's record-keeping signature rules


Palatine, IL— Schneider Electric and Stelex-TVG Inc. (Bensalem, PA) released a joint white paper on Aug. 22 to help

The white paper covers Schneider Electric's existing automation hardware and software product lines, which are used in pharmaceutical plants. Products addressed in the paper include Modicon TSX Quantum and Momentum processors and I/O modules, as well as Concept, One Step Link and One Step Generator programming and SCADA software. Also, Stelex evaluated upgrade paths for Compact 984, 984 (800 Series I/O) and Modsoft legacy products.

'As the FDA's interpretation of 21 CFR 11 evolves, we believe that it must eventually get to the real source of plant automation data, the programmable logic controller,' says Stephen Larson, Schneider's global pharmaceutical marketing manager. 'This white paper will help our customers achieve compliance on their legacy systems, as well as drive our product development efforts to create new products that are compliant right out of the box.'

Daniel Matlis, Stelex's business development director, adds that, 'Anyone involved with FDA compliance will find this white paper very useful. It provides the pharmaceutical industry with a tangible direction in meeting the regulatory requirements of 21 CFR 11. We're pleased to be working with Schneider Electric in this important effort to translate federal standards to the actual equipment working in pharmaceutical plants.'

Steven Pogrebivsky, a Stelex principal and one of the paper's authors, says that one of the biggest challenges facing pharmaceutical companies is how to make the programmable logic controllers and software used to develop PLC programs compliant with the federal regulations for electronic record keeping and electronic signatures.

'The goal of this white paper is to specifically address these regulations and provide detailed guidance for customers using Schneider Electric's automation hardware and software,' says Mr. Pogrebivsky. 'These suggestions will assist customers with existing and future installations to bring their operations into compliance with 21 CFR Part 11 regulations.'

To download a copy of this 21 CFR Part 11 compliance white paper, visit .

Control Engineering Daily News Desk
Jim Montague, news editor

No comments
The Engineers' Choice Awards highlight some of the best new control, instrumentation and automation products as chosen by...
The System Integrator Giants program lists the top 100 system integrators among companies listed in CFE Media's Global System Integrator Database.
The Engineering Leaders Under 40 program identifies and gives recognition to young engineers who...
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.
Motor specification guidelines; Understanding multivariable control; Improving a safety instrumented system; 2017 Engineers' Choice Award Winners
Selecting the best controller from several viewpoints; System integrator advice for the IIoT; TSN and real-time Ethernet; Questions to ask when selecting a VFD; Action items for an aging PLC/DCS
Robot advances in connectivity, collaboration, and programming; Advanced process control; Industrial wireless developments; Multiplatform system integration
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 the Industrial Internet of Things (IIoT) and how it is transforming manufacturing.

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

Future of oil and gas projects; Reservoir models; The importance of SCADA to oil and gas
Big Data and bigger solutions; Tablet technologies; SCADA developments
SCADA at the junction, Managing risk through maintenance, Moving at the speed of data
Automation Engineer; Wood Group
System Integrator; Cross Integrated Systems Group
Jose S. Vasquez, Jr.
Fire & Life Safety Engineer; Technip USA Inc.
click me