Risk Management begins with our compliance expertise. 20+ years of it to be exact. We approach every engagement with the validation rigor that is commensurate with the intended use of the system, regulatory requirements, technical complexity, business risk, and data integrity risk.
Our auditing team conducts cloud and on-premise software vendor assessments, PAI audits, GXP readiness, Inspection readiness, 3rd Party audits, and audits specific to regulations such as UDI, DSCSA, Part 11, and many others. Our Compliance Center of Excellence leaders are comprised of ex-Agency personnel who successfully remediate customers in any stage of agency scrutiny.
Want to sleep better at night knowing your GxP processes and applications are properly qualified and validated? Give us a call.
Want to talk technology? Don't get us started! We can discuss benefits and features all day long, but more than talking about it, we love seeing technology implemented in the right way, with compliance, and heavily adopted and loved by your users. Cloud, mobile, collaboration, IoT, Part 11 eSignature...we could go on. Just know that we partner with vendors that can be qualified and have solutions that we implement, validate, and support. Being able to say, "Implemented by USDM" means your company is using technology to innovate, stay ahead of the competition, excite employees, and in the end, create better products and services for your customers.
Have a process or idea you'd like to see optimized, put in the cloud, with lower maintenance and cost? The USDM Life Sciences Digital Transformation team knows just what to do.
The wisdom of our industry leaders with documented best practices is unmatched.
- Supply Chain
We know the rules and speak the language. All we do is Life Sciences. Contact us today for an evaluation of your processes to see where your Digital Transformation begins or really takes off.