Title :
Assessment of quality critical software in the pharmaceutical industry
Author_Institution :
Comput. Validation Manager, ICI Pharm., Macclesfield, UK
Abstract :
Concerns the operation of manufacturing computer systems in the Pharmaceutical Industry in a regulated environment called Good Manufacturing Practice (GMP). The main point that the author makes is that the Pharmaceutical Industry has to prove to the regulatory authorities that it is in control of its computer systems. He discusses regulatory requirements, a method of complying with the requirements which involves identifying threats and providing controls to mitigate these threats. The study identifies potential safety or quality problems in a plant computer system
Keywords :
manufacturing computer control; medical computing; quality control; software reliability; GMP; Good Manufacturing Practice; Pharmaceutical Industry; manufacturing computer systems; plant computer system; regulatory requirements;
Conference_Titel :
Managing Critical Software Projects, IEE Colloquium on
Conference_Location :
London
