Compliance Gurus specializes in compliance auditing services, including software vendor audits as well as Computer System Validation (CSV) and Computer Software Assurance (CSA) audits of your validation packages.

The FDA requires FDA regulated organizations to perform their due diligence on software vendors prior to selection, validation, and implementation of GxP software applications. However, often times we find that so many clients select and purchase their GxP software application without performing a software vendor audit. In these instances, we advise our clients that we can still execute the software vendor audit as long as it is performed prior to the implementation of their GxP software application.

We do, however, highly advise our clients to audit the software vendor before selecting the software in order to ensure the GxP software application is 21 CFR Part 11 compliant and ascertain the cost of ownership by determining if any configurations or customizations (code changes) are required to meet the user requirements. Compliance Gurus can assist your company through every step of the audit process. We do not recommend to our clients to purchase any software validation templates from the said software vendor, as 95% of the time, software vendors that sell their software to the FDA regulated space lack the 21 CFR Part 11 expertise and therefore, their software validation templates are not FDA compliant. As a result, we have had several clients asking our firm to update their vendor templates to be FDA compliant.

Periodic reviews of GxP applications are also required via 21 CFR Part 11 to ensure GxP applications remain in a validated state throughout their lifecycle. Quite often, our smaller to medium sized clients ask us to perform a one off assessment of their CSV or CSA validation package to ensure it is 21 CFR Part 11 compliant as they often lack a CSV or CSA SME in-house.