APOGEE

Siemens' Bundled Solution Helps Facilities Comply With 21 CFR Part 11 Requirement for Electronic Records and Signatures

BUFFALO GROVE, Ill. (Jan 5, 2004) - A leader in environmental monitoring and control systems for FDA-regulated industries, Siemens Building Technologies, Inc., has developed its next-generation bundled solution for building automation system compliance with 21 CFR Part 11. The solution helps industries regulated by the FDA to comply with requirements to store signatures and records electronically.

21 CFR Part 11 was introduced in the '90s in response to pharmaceutical companies' request 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.

The Siemens bundled solution for FDA-Regulated Facilities includes the company's APOGEE® Building Automation System to address the technological elements of Part 11 compliance, as well as a comprehensive series of APOGEE Building Automation Services that focus on the procedural elements of compliance. All the components are flexible and can be tailored to specific requirements and requests.

Technological elements in the solution include automated audit trails, electronic signatures and data security. The procedural elements include Part 11 gap analysis, compliance remediation and ongoing consultation (see table for complete list of elements).

Addressing the need for full, long-term compliance, Siemens also maintains a dedicated Part 11 Compliance Team to oversee ongoing development of its compliance efforts and to guide and support its field organization in the progressive applications of its Part 11 compliance solution.

Going one step further to address the full set of needs at a pharmaceutical manufacturing site, this solution also focuses on meeting the rigorous facility requirements of 21 CFR Parts 210 and 211 (current Good Manufacturing Practices).

Headquartered in Buffalo Grove, Ill., Siemens Building Technologies, Inc., is one of 14 Siemens operating companies in the United States and is a leading single-source provider of cost-effective facility performance solutions for the comfort, life safety and security of some of the most technically advanced buildings in the world. In North America, Siemens Building Technologies employs 8,000 people and provides local service from more than 100 locations coast-to-coast. Worldwide, the company has 33,000 employees and operates in 125 countries.

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