Regulators expect companies to assess and approve the vendors of their critical software and systems. We have the experienced, certified auditors to audit system suppliers on your behalf.
Regulatory Agencies Expect that Your Software Vendors are Validated
FDA regulations, such as 21 CFR Part 820, require documented evaluations of suppliers, including software vendors.
The FDA’s General Principles of Computer System Validation, recommends auditing the design, development and testing methodologies of off-the-shelf software vendors.
International regulators have similar expectations. For example, Eudralex’s Annex 11 states that “audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request.”
We Can Audit Your Software Vendors for You
When you don’t have the time or experience to audit your software vendors, we can step in to perform the audit on your behalf. Our certified quality auditors can work with you to:
- Establish the audit standards, audit criteria, agenda and 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
Have Confidence That Your Software Vendors are Compliant
Our auditors have been on both sides of the audit table. This experience allows us to perform efficient, effective software vendor audits, so both you and your software vendor can get back to business. And, you will have the documentation to support your validation strategy and demonstrate regulatory compliance.