Is it possible to recreate, amend or delete original data and metadata;Controls over paper records are discussed elsewhere in this guidance.Computerised system controls may be more complex, including setting of user privileges and system 19、 configuration to limit or prevent access to amend data. ...
Impact of the introduction of computerised physician order entry (CPOE) on the surveillance of restricted antimicrobials and compliance with policy Prescribers at a 400-bed metropolitan teaching hospital applied for approval to prescribe restricted antimicrobials using Guidance DS (GDS), an electronic .....
工艺结果是否开放或定义是否明确 This ensures that manual interfaces with IT systems are considered in the risk assessment process. Computerised system validation in isolation may not result in low data integrity risk, in particular when the user is able to influence the reporting of data from the ...