Bespoke Risks associated with the database must be identified e.g. risk Completed risk assessment Risk Assessment Configured of data corruption etc. Measures to mitigate risks should be document Off-the-Shelf described. Bespoke Detailed plan endorsed by the database programmer including: Validation Plan Configured Authorised validation plan user requirement specification and functional specification Off-the-Shelf Completed validation report including: test failures with Bespoke resolution; user acceptance testing; code testing; confirmation Authorised, completed validation Validation Report Configured that eCRF data are mapped to the appropriate locations in the report Off-the-Shelf database. Bespoke If agreed necessary, with the CI, sponsor and programmer, a User manual/Instruction User Instructions Configured user manual/instructions will be prepared, to be provided to documents Off-the-Shelf users with rights to enter data. Bespoke If agreed necessary, with the CI, sponsor and programmer, Configured Training Records Plan for training e.g. SIV agenda. training will be provided to users with rights to enter data. Off-the-Shelf Bespoke Record of when testing is complete and the database system Communication of operation date Record of Release Configured is operational and can receive trial data. to users Off-the-Shelf Bespoke Performance Testing that operational elements are fit for purpose e.g. for Configured Document of results of tests Qualifications excel, formatting of cells and testing of formulae Off-the-Shelf Bespoke There must be a mechanism to allow data to be verified, e.g. QC Check Configured Data monitoring plan or QC plan QC check. There must also be a plan for verification. Off-the-Shelf Bespoke A time point to lock the database must be given. It must be Database Lock Configured Data monitoring plan possible to unlock the database if necessary. Off-the-Shelf QA Representative Signature Position Date
Bespoke Configured Off-the-Shelf Risk Assessment Risks associated with the database must be identified e.g. risk of data corruption etc. Measures to mitigate risks should be described. Completed risk assessment document Bespoke Configured Off-the-Shelf Validation Plan Detailed plan endorsed by the database programmer including: user requirement specification and functional specification Authorised validation plan Bespoke Configured Off-the-Shelf Validation Report Completed validation report including: test failures with resolution; user acceptance testing; code testing; confirmation that eCRF data are mapped to the appropriate locations in the database. Authorised, completed validation report Bespoke Configured Off-the-Shelf User Instructions If agreed necessary, with the CI, sponsor and programmer, a user manual/instructions will be prepared, to be provided to users with rights to enter data. User manual/Instruction documents Bespoke Configured Off-the-Shelf Training Records If agreed necessary, with the CI, sponsor and programmer, training will be provided to users with rights to enter data. Plan for training e.g. SIV agenda. Bespoke Configured Off-the-Shelf Record of Release Record of when testing is complete and the database system is operational and can receive trial data. Communication of operation date to users Bespoke Configured Off-the-Shelf Performance Qualifications Testing that operational elements are fit for purpose e.g. for excel, formatting of cells and testing of formulae Document of results of tests Bespoke Configured Off-the-Shelf QC Check There must be a mechanism to allow data to be verified, e.g. QC check. There must also be a plan for verification. Data monitoring plan or QC plan Bespoke Configured Off-the-Shelf Database Lock A time point to lock the database must be given. It must be possible to unlock the database if necessary. Data monitoring plan QA Representative Signature Position Date
GS002-T02%20Computer%20System%20Validation%20Checklist%20v3.0.docx