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 Configuration/system
and when it was done. The audit trail must be accessible by 3 rd
Configured Audit Trail parties. The audit trail must be applicable to data provided
specifications. Demonstrate audit
Off-the-Shelf trail to the sponsor.
directly by 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
Bespoke Regulatory authorities and representatives of the sponsor must
Configured rd be able to view data in the database. This should be on a read Demonstrate access to sponsor
Off-the-Shelf 3 Party Access only basis i.e. without the ability to alter/delete/add data.
Bespoke The database should allow necessary access, to all relevant
Configured Period Access parties, for the entire period that the data/information must be Design specifications
Off-the-Shelf retained according to the protocol.

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Bespoke Risks associated with the database must be identified e.g. risk
Completed risk assessment
Configured Risk Assessment of data corruption etc. Measures to mitigate risks should be
document
Off-the-Shelf described.
Bespoke
Detailed plan endorsed by the database programmer including:
Configured Validation Plan user requirement specification and functional specification
Authorised validation plan
Off-the-Shelf
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 database 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
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.
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

QA Representative Signature Position Date

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