We Can Audit Your Software Vendor
When you don’t have the time or experience to audit your software vendors, we can perform the audit on your behalf.
FDA regulations, such as 21 CFR 820, require documented evaluations of suppliers, including software vendors. International regulators have similar expectations.
We deliver efficient, effective software supplier audits and the supporting documentation to demonstrate regulatory compliance, so both you and your software vendor can get back to business.
Get help auditing your vendor“Audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request.” - PIC/S and Eudralex Annex 11
Customer Success Story
A CRO planned to move to a SaaS (software as a service) solution for clinical trial management, but had limited experience in FDA electronic records regulations, such as 21 CFR Part 11, and software vendor audits. We audited their SaaS vendor, prepared the Audit Report, and coordinated corrective action requests.
As a result, the CRO had the documentation needed for their own audits by study sponsors and the justification to reduce internal computer system validation activities without adverse impact on study participants.
We are experienced certified auditors who have been on both sides of the audit table.
Our experienced team of auditors will:
- Establish the audit standards, audit criteria, agenda and audit checklist
- Arrange the audit with your software vendor
- Manage the opening meeting, discovery stage, and closing meeting
- Author the audit report
- Meet with you to ensure that you understand the audit report and its implications
Get Help Auditing Your Vendor
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Let's Talk About Your Software Vendor Audit
+1 (847) 295-7160
