SVC / 06

CSV Audit

An independent audit of your computerised systems, validation documentation and data integrity controls — with a prioritized remediation roadmap ahead of a regulatory or customer inspection.

What's Included

Scope of the engagement

[✓]System inventory and validation status review

[✓]Documentation gap assessment against GAMP 5, Part 11 and Annex 11

[✓]Data integrity and ALCOA+ controls review

[✓]Mock inspection interviews and walkthrough

[✓]Risk-ranked findings register

[✓]Remediation roadmap with effort estimates

Other Services

Process Control System Validation

Laboratory Software Validation

Enterprise Software Validation

Excel Spreadsheet Validation

Temperature Mapping

Free Consultation

Get a Free Consultation

Tell us about your systems. We will map them to GAMP 5 and outline the path to an audit-ready state — at no cost.

WHATSAPP CHAT EMAIL THE TEAM