Data 6. The system should include, where appropriate, built-in Clarification of Nil checks of the correct entry and processing of data. requirements; 5. Computerised systems exchanging data electronically with other systems should include appropriate built-in Providing checks for the correct and secure entry and processing of further detail on data, in order to minimize the risks. existing requirements; Accuracy checks 8. Data should only be entered or amended by persons Reduction of Minor authorised to do so. Suitable methods of deterring prescriptive 6. For critical data entered manually, trial should be an unauthorised trial of data include the use of keys, pass character of additional check on the accuracy of the data. This check cards, personal codes and restricted access to computer requirements; may be done by a second operator or by validated terminals. There should be a defined procedure for the electronic means. The criticality and the potential Clarification of issue, cancellation, and alteration of authorisation to enter consequences of erroneous or incorrectly entered data to requirements and amend data, including the changing of personal a system should be covered by risk management. passwords. Consideration should be given to systems allowing for recording of attempts to access by unauthorised persons. 9. When critical data are being entered manually (for example the weight and batch number of an ingredient during dispensing), there should be an additional check on the accuracy of the record which is made. This check may be done by a second operator or by validated electronic means. Data storage 14. Data should be protected by backing-up at regular Clarification of Minor intervals. Back-up data should be stored as long as requirements 7.1 Data should be secured by both physical and necessary at a separate and secure location. electronic means against damage. Stored data should be
Data 5. Computerised systems exchanging data electronically with other systems should include appropriate built-in checks for the correct and secure entry and processing of data, in order to minimize the risks. 6. The system should include, where appropriate, built-in checks of the correct entry and processing of data. Clarification of requirements; Providing further detail on existing requirements; Nil Accuracy checks 6. For critical data entered manually, should be an additional check on the accuracy of the data. This check may be done by a second operator or by validated electronic means. The criticality and the potential consequences of erroneous or incorrectly entered data to a system should be covered by risk management. 8. Data should only be entered or amended by persons authorised to do so. Suitable methods of deterring unauthorised of data include the use of keys, pass cards, personal codes and restricted access to computer terminals. There should be a defined procedure for the issue, cancellation, and alteration of authorisation to enter and amend data, including the changing of personal passwords. Consideration should be given to systems allowing for recording of attempts to access by unauthorised persons. 9. When critical data are being entered manually (for example the weight and batch number of an ingredient during dispensing), there should be an additional check on the accuracy of the record which is made. This check may be done by a second operator or by validated electronic means. Reduction of prescriptive character of requirements; Clarification of requirements Minor Data storage 7.1 Data should be secured by both physical and electronic means against damage. Stored data should be 14. Data should be protected by backing-up at regular intervals. Back-up data should be stored as long as necessary at a separate and secure location. Clarification of requirements Minor trial trial
consult-manuf-automatic-adoption-pics-130529-comparison.docx