Compliance responses for Siemens products

The requirements on computerized System used in pharmaceutical manufacturing are constantly growing. Nonetheless regulated companies have to support documented evidence that a system is fit for its intended use.

Compliance responses do document:

  • the conformity of Siemens products with requirements for systems handling electronic records and electronic signatures

  • the conformity with other requirements from 21 CFR Part 11 as well as those from Annex 11 of the EU GMP guide

  • the development and production of Siemens products according to our quality management system

These materials are commonly used:

  • for the selection of products and components for a given set of requirements

  • during the determination of the specification and validation strategy

  • as documented evidence for conformance with regulatory requirements