Recent observation on Computer controls
Administrative privileges assigned to analyst.
Deletion of Test results and aborted sample set results .
Lack of Standard operating procedure for Audit trail review.
Trail run or Trail work .... unacceptable practice
DGM- IT & GxP Support
4 年in order to achieve this - O/S level & application level hardening with proper SOP and protocol to show what was done
CSV, CSA, IT Compliance
5 年This was issued to which company
Chief Executive Officer | Low Code aPaaS for Lifesciences
5 年When the systems are not connected with Network then administrative permissions were given to Analyst. Sometimes given permissions are not revoked. You can keep the restrictions in the Standalone systems by applying restrictions like No Copy, No Edit, No New Document etc.. Need to create a O/S level program to achieve this. We have done this at 3rd Largest Pharma company in INDIA.