Siemens says its 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 1990s, 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 addressed the requirements of Part 11 compliance with the 1998 introduction of “InfoCenter Suite” to its “Workstation” software line. Since then, the company says it 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 ongoing 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 include: