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Reliable and trustworthy records for the pharmaceutical and food & beverage industry with SIMATIC WinCC Open Architecture

The requirements for computerized systems in pharmaceutical manufacturing and production continue to increase. At the same time, suitability for the intended use must be documented and proven for each system. SIMATIC WinCC Open Architecture meets all the technical requirements for the use of electronic records and electronic signatures.

Declarations of the manufacturer and declarations of conformity:

  • prove that the products comply with the requirements for the storage of electronic records and electronic signatures,

  • explain compliance with additional requirements of 21 CFR Part 11 and Annex 11 of the EU Good Manufacturing Practice (GMP) guidelines, and

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

Details about 21 CFR Part 11:
In August 1997, the regulations of the 21 CFR Part 11 Electronic Records; Electronic Signatures of the US Food and Drug Administration (FDA), the American regulatory and supervisory body, became effective. These regulations define the acceptance criteria for the use of electronic records and electronic signatures, which must be just as reliable and trustworthy as, and equivalent to, records in paper form and handwritten signatures on paper..