What we do
Life Sciences Expertise
Understanding your organization’s compliance and technology maturity helps you to know where you are today, and where your people, processes, and technology need to be to compete tomorrow.
Too little effort and you compromise product quality and patient safety. Too much effort and 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.
We help our customers develop, optimize, and automate their GxP processes and we can help you, too. Focusing exclusively on life sciences customer challenges for more than 20 years, our domain expertise is unmatched. Through collaboration with global health authorities and the world’s leading technology companies, we continue to improve and innovate on solutions customized for regulated biotech, pharma, and medical device customers whose businesses depend on achieving and maintaining compliance.
A new guidance document from the U.S. Food and Drug Administration (FDA) is still on the horizon for Computer Software Assurance (CSA). This is intended for life sciences companies and their manufacturing, operations, and quality system software; it will not apply to product software. The FDA has clearly stated the approach can be used today and USDM has implemented CSA methodologies for many of our customers. Learn more about our CSA services here.
Data Integrity and Cybersecurity Services for Regulatory Compliance
Even early-stage life sciences organizations generate valuable intellectual property and stakes rapidly increase in the clinical and commercial phases. It is never too early to begin protecting yourself from cybersecurity threats and risks. USDM has a knowledgeable and experienced staff that will help you meet FDA expectations for good cybersecurity practices such as preventing unauthorized user access, ensuring trusted content, and maintaining data confidentiality.
USDM can also assess your current data integrity system and provide a tailored improvement plan to build a data integrity program that fits your company’s risks and priorities.
Unique Device Identification (UDI) and the European Union Medical Device Regulation (EU MDR)
USDM is the industry leader in UDI regulatory compliance solutions for the medical device industry. We have well-established relationships with the most prominent IT vendors in the world, and an experienced team of subject matter experts 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 MDR efforts.
Customized Compliance Training & Education Programs
USDM offers a variety of customized training programs to educate internal teams or external partners and help them stay up to date on the rapidly changing regulatory landscape. Learn more about our GxP training and education programs here.