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Siemens Bundled e-Records/Signatures Solution Delivers Unique
21 CFR Part 11 Compliance for FDA-Regulated Industries
BUFFALO GROVE, IL, (October 2002)- Leveraging its many years' experience delivering automated environmental monitoring and control systems for FDA-regulated industries, Siemens Building Technologies announced today its APOGEE Compliance Solution, a bundled technological and procedural solution to 21 CFR Part 11.
Siemens bundled solution electronically captures building operation and environmental condition records and their associated signatures in a secure format to help pharmaceutical, biotech and medical device companies achieve and maintain compliance with 21 CFR Part 11. The technological and procedural elements of the solution are provided through Siemens' APOGEE Building Automation System and Building Automation Services.
In the '90s, in response to pharmaceutical companies' request for guidelines on submitting and storing data electronically, the Food and Drug Administration added Part 11 to Title 21 in the Code of Federal Regulations. Part 11 establishes criteria under which the FDA considers electronic records and signatures reliable and equivalent to paper records and handwritten signatures.
Siemens was the first building automation supplier to address the requirements of Part 11 compliance with the 1998 introduction of InfoCenter Suite to its Workstation Software line. Since then, the company has worked in research, production and warehousing environments at a number of FDA-regulated sites across North America, helping them develop Part 11 gap analyses on their building automation systems and providing a system-wide installed solution and on-going maintenance.
The technological elements of the APOGEE Compliance Solution provided by the building automation system include data security, electronic signatures, automated audit trails, record/signature linking, system/device checks and system validation. The procedural elements of the solution are addressed in a series of Automation Services which includes:
- Compliance services such as validation, change control and development of Standard Operating Procedures
- Part 11 Gap Analysis Assessments
- Ongoing consulting
- Training
- Engineering support
- Facility operations services
Addressing the need for full, long-term compliance one step further, Siemens also maintains a dedicated Part 11 Compliance Team at its corporate headquarters to oversee development of its compliance efforts and to guide and support its branch network in the application of its Part 11 compliance solution in the field.
Siemens Building Technologies, Inc., is the North American affiliate of Zurich-based Siemens Building Technologies (SBT) AG, the leading single-source provider of cost-effective facility performance solutions for the comfort, life safety, security, energy efficiency and operation of some of the most technically advanced buildings in the world. In North America, SBT employs 8,500 professionals and provides local service from more than 400 locations coast-to-coast. Worldwide, SBT employs 33,000 and serves customers in more than 125 countries.
APOGEE is a trademark of Siemens Building Technologies, Inc.
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