The Use of Safety-Case document for evaluation and guarantee of security software and information technology at the pharmaceutical enterprise

Abstract

The Safety-Case methodology of provision and safety proof of ASC technological process of drugs’ manufacturing have been considered; standard items of Safety-Case document as an evidence of the functional safety of used control system automated process of drugs’ manufacturing at the pharmaceutical enterprise have been proposed.

Keywords

• Safety-Case document
• software
• pharmaceutical enterprise
• technological process of manufacture
• drug
• ICS of critical used
• safety