How long does a data integrity audit take?
A typical data integrity audit takes 4-6 weeks.
Data Integrity Audit
Data integrity audit services for pharmaceutical manufacturers. The engagement covers the MHRA-style assessment, the gap analysis, the remediation roadmap, the ALCOA+ compliance review, and the inspector-readiness verification.
MHRA-style assessment
The MHRA-style assessment covers the data lifecycle (creation, processing, reporting, retention, retrieval), the metadata, the audit trail, the access control, the data review, the data integrity controls, and the periodic review.
Gap analysis
The gap analysis identifies the gaps in the data integrity controls, the documentation, the operating routine, the change control, and the periodic review.
Remediation roadmap
The remediation roadmap defines the corrective actions, the preventive actions, the responsible owners, the dates, and the evidence of completion.
How to use this page
Use this Data Integrity Audit page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For Data Integrity Audit, prepare the records, owners, risks and decision criteria linked to mhra-style assessment, gap analysis, remediation roadmap. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
What is the difference between data integrity audit and validation audit?
A data integrity audit focuses on the data integrity controls. A validation audit focuses on the validation package.