Life Sciences Expertise

Understand your organization’s compliance and technology maturity today and how to compete with your people, processes, and technology tomorrow.

With too little effort, you compromise product quality and patient safety. With too much effort, you overwhelm your Quality and IT teams with massive workflows and an overabundance of verification activities. You need a strategic, balanced, and sustainable approach to compliance that creates a competitive advantage.

Develop, optimize, and automate your GxP processes with the help of USDM Life Sciences. Our focus has been on life sciences customer challenges for more than 20 years and our domain expertise is unmatched. We work with global health authorities and the world’s leading technology companies to deliver customized solutions for regulated biotech, pharma, and medical device customers whose businesses depend on achieving and maintaining compliance.

Computer Software Assurance

The U.S. Food and Drug Administration (FDA) issued its draft guidance for Computer Software Assurance (CSA) in September 2022. It’s intended for life sciences companies and their manufacturing, operations, and quality system software; it does not apply to product software. The FDA has clearly stated that the CSA approach can be used today and USDM has modernized and streamlined this approach to Computer System Validation for many of our customers.

Data: Your most valuable asset

Your data is the lifeblood of your organization. How you access it, store it, move it, and back up and archive it is all part of your data management and data integrity strategy. Trust USDM to assess your current strategy and provide an improvement plan tailored to your company’s risks and priorities.

Cybersecurity and risk management

Even early-stage life sciences organizations generate valuable intellectual property, so it’s never too early to protect yourself from cybersecurity threats and risks. USDM’s knowledgeable and experienced staff helps you meet FDA expectations for good cybersecurity practices such as preventing unauthorized user access, ensuring trusted content, and maintaining data confidentiality.

UDI and EU MDR

USDM is the industry leader in Unique Device Identification (UDI) regulatory compliance solutions for the medical device industry. We have well-established relationships with the most prominent IT vendors in the world. An experienced team of subject matter experts is led by Jay Crowley, who developed the framework and authored key requirements for the FDA’s UDI system. We can help your organization execute a scalable program to support your UDI and European Union Medical Device Regulation (EU MDR) efforts.

Custom GxP Compliance Training & Learning Programs

Help your internal teams or external partners stay up to date on the rapidly changing regulatory landscape. You tell us what you need and we’ll create training programs to meet your objectives.