Sample Audit Checklist

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

Hi

I have been asked to audit a computer system for another company that are currently not working in a compliant based environment but hope to move into Biotechnology soon. In order for them to do this they need the system in question fully validated.

For me to audit this system and point them in the right direction as to what they need to do to bring the system up to the required standard I need to audit this system.

Can anyone point me in the right direction as to what questions I should be asking or does anyone know where I can find a sample audit checklist

Kind Regards

2

Kenny - You need to take a seriously close look at GAMP4, Section M2 (Guideline & Checklists for Supplier Audits), Attachments M2/A to M2/H and Attachments M2/2A to M2/2E.

The overview is all there.

Hope this helps.

3

Cheers DaveH,

I see what you mean all of the information that is required to know is there.

GAMP 4 is useful after all.

Thanks

Kenny Soman