Schneider, Stelex show how to comply with FDA's record-keeping signature rules
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.'
Control Engineering Daily News Desk
Jim Montague, news editor