COMPUTER SYSTEM VALIDATION CHECKLIST

Study Title:
Manufacturer/Vendor:
Programmer/Designer:
Clinical Trials Monitor:
Trial Manager:
Use of System:

System: Bespoke Configured Off-the-Shelf

Requirements of System For a Clinical Trial

Requirements Check Item Description of check Evidence Comments

There must be the ability to verify who entered/changed data,
Bespoke when it was done. The reason for any change must also be Configuration/system
Configured Audit Trail recorded. The audit trail must be accessible by 3rd parties. The specifications. Demonstrate audit
Off-the-Shelf audit trail must be applicable to data provided directly by trail to the Sponsor.
subjects e.g. diary data.
Bespoke
There must be a reason for change and a source (individual or
Configured Change request group) of the change
SOP or procedure describing this
Off-the-Shelf
Bespoke
Configured Approval of change Approval from programmer/designer and from CI/PI SOP or procedure describing this
Off-the-Shelf
SOP or procedure describing this
Bespoke The change must be tested and any failures and corrections
including; test plan, record of (no)
Configured Testing recorded. The validated state must be maintained after any
failures and corrections, validation
Off-the-Shelf system change.
certificate or equivalent
Bespoke Update of the system must be communicated to affected
Configured Release individuals. Date of release of the new version of the system SOP or procedure describing this
Off-the-Shelf must be recorded.
Bespoke
There must be a method to ensure any interaction of systems Completed tests demonstrating no
Configured Systems Interactions e.g. transfer or merging of data does not corrupt data issues or the resolution of issues
Off-the-Shelf
Bespoke
The system must have measures to back-up data in case data Written description of back up
Configured Back-up is lost. There must be a disaster recovery plan. measures
Off-the-Shelf
Regulatory authorities and representatives of the Sponsor
Bespoke
must be able to view data in the computer system. This should
Configured Demonstrate access to Sponsor
3rd Party Access be on a read only basis i.e. without the ability to
Off-the-Shelf
alter/delete/add data.
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Bespoke The computer system should allow necessary access, to all
Configured Period Access relevant parties, for the entire period that the data/information Design specifications
Off-the-Shelf must be retained according to the protocol.
Bespoke Risks associated with the computer system must be identified
Completed risk assessment
Configured Risk Assessment e.g. risk of data corruption etc. Measures to mitigate risks
document
Off-the-Shelf should be described.
Bespoke Detailed plan endorsed by the computer system programmer
Configured Validation Plan including: user requirement specification and functional Authorised validation plan
Off-the-Shelf specification
Completed validation report including: test failures with
Bespoke
resolution; user acceptance testing; code testing; confirmation Authorised, completed validation
Configured Validation Report 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
Configured User Instructions 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 training will be provided to users with rights to enter data.
Plan for training e.g. SIV agenda.
Off-the-Shelf
Bespoke
Record of when testing is complete and the computer system Communication of operation date
Configured Record of Release 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
Off-the-Shelf Qualifications excel, formatting of cells and testing of formulae
Bespoke
There must be a mechanism to allow data to be verified, e.g.
Configured QC Check QC check. There must also be a plan for verification.
Data monitoring plan or QC plan
Off-the-Shelf
Bespoke
A time point to lock the database must be given. It must be
Configured Database Lock possible to unlock the database if necessary.
Data monitoring plan
Off-the-Shelf
Bespoke
Review will be completed by the Clinical Trials Monitor prior to
Configured CRF Review final validation of the computer system
Completed CRF review document
Off-the-Shelf

QA Representative Signature Position Date

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