USDM Life Sciences provides compliance and validation solutions for DocuSign's life sciences customers.

Working together, DocuSign and USDM will facilitate compliance with the FDA's 21 CFR Part 11 regulation. USDM has worked extensively with DocuSign to provide comprehensive implementation services that get your instance up and running quickly. Some customers have had DocuSign 21 CFR Part 11 instances live in 7 days. 

USDM has validated more than100 DocuSign systems using proven methodologies, document templates, and processes based on life sciences best practices. By leveraging DocuSign and USDM’s expertise, you can benefit from our extensive implementation knowledge and templates. For instance, you will no longer need to create your documents from scratch but can leverage our library of resources. Once DocuSign is fully validated through USDM’s services, required systems configurations can be modified via change control processes.  

Key Benefits:

  • USDM enables pharmaceutical, biotechnology, and medical device customers to use DocuSign’s 21 CFR Part 11 eSignature solution for regulated business processes and workflows.
  • USDM's Cloud Assurance managed services for DocuSign provides a comprehensive implementation solution to meet 21 CFR Part 11 requirements.
  • USDM helps life sciences companies rapidly deploy DocuSign to alleviate current business continuity and compliance bottlenecks.
  • Achieve and maintain continuous cloud compliance and manage new releases.
  • Comply with new regulations such as the California Consumer Privacy Act (U.S), HIPAA (U.S.), Annex 11 (E.U)., GDPR (E.U.), ERES (Japan), and ISO 27001:2013.
  • Import documents and data with pre-built integrations and regulated capabilities.
  • Collect validated information to authenticate the identity of patients, investigators, and employees around the world. 
  • Automatically update systems and trigger processes once an agreement is signed.

More Information:

USDM Services

DocuSign Case Study: DocuSign in 7 Days to Enable eSignatures for Remote Work

Part 11 Blog: USDM's Guide to 21 CFR Part 11 Compliance