REDCap validation for regulated contexts

When REDCap is used in regulated contexts or under quality review (clinical trials, observational studies with traceability requirements, data integrity processes), structured validation is needed. Depalop provides a computer system validation package designed for Sponsors, QA and Auditors, according to GCP, EU Annex 11 and FDA 21 CFR Part 11.

1) Platform validation (REDCap Core)

Checks on user and role management, access controls, audit trail, session security, exports and reports, data integrity. The result is a reusable documentation baseline for later studies.

2) Project validation (Project-Specific)

Checks on data dictionary, validation rules, branching logic, calculated fields, data entry behaviour, classic or longitudinal projects and study-specific requirements. The result is ready to be filed in the TMF/eTMF.

• Traceability matrix linking requirements, specifications, tests and evidence
• Test evidence, organised and traceable
• Execution reports with references and timestamps
• Validation Summary Report (VSR) for stakeholders, QA and audits
• Integrity checks for the delivered package

CROs and Sponsors, clinical sites and research institutes, study groups with data integrity requirements and teams that need to standardise validation across several REDCap projects.

See also: REDCap consulting.

Request a preliminary assessment of your REDCap project.

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