What It Is
In regulated industries, the determination of fit for purpose starts with the software manufacturer. This white paper outlines a professional framework for conducting software vendor audits. By evaluating a vendor’s software development lifecycle (SDLC), quality procedures, and validation rigor, you can determine if their product is built to stand up to regulatory scrutiny—and potentially leverage their existing documentation to reduce your own validation workload.
Who It's For
This resource is essential for quality assurance (QA) auditors, IT compliance managers, and informatics procurement teams who are evaluating new LIMS, ELN, or CDS vendors and need a standardized method to assess risk.
How to Use It
Request this white paper to build your custom audit protocol. The guide details five critical areas of evaluation: SDLC maturity, manufacturing procedures, validation and 21 CFR Part 11 compliance, issue tracking, and corrective actions.
-(1).png?width=200&height=71&name=CSolsLongLogo_white_tagline-(1)-(1).png)