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.


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

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