Glossary

System Owner

The person responsible for the availability and maintenance of a computerised system and for the security of the data it holds.

Source · EudraLex Volume 4, Annex 11 (2011), Glossary: System owner

Details

The system owner is responsible for the technical state, security, maintenance, and availability of the system and works with the process owner and the quality unit. Inspections cite no owner assigned, or the role delegated wholly to IT so that decisions on privileges, changes, backups, and periodic review sit outside the quality procedures. Look at the role description, the system inventory, and the approval records for privileges, changes, incidents, backups, and periodic review.

Related sections

Related terms

Source

EudraLex Volume 4, Annex 11 (2011), Glossary: System owner

GRM Regulatory Glossary

243 GMP terms in one place

Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.

Browse the whole glossary
Weekly Newsletter

New GMP inspection findings, every Monday

Every Monday we email the week's new inspection records from the FDA, EMA, Health Canada and MFDS, with a short summary of the week's regulatory news. We'll also let you know when the site gains new features. Unsubscribe any time with one click.

See recent findings first

Sent every Monday · a confirmation email follows when you subscribe · unsubscribe from the footer of any email.