Globally compliant eSignatures and digital agreements
The global pandemic has created an urgent need to enable remote work and minimize the disruption to business continuity. If your company is now working remotely and you have a pressing need to sign regulated documentation electronically, USDM can help.
Working together, DocuSign and USDM Life Sciences will ensure you comply with the FDA's 21 CFR Part 11 regulation. At USDM, we have perfected our DocuSign implementation to get you up and running in as fast as 7 DAYS! USDM has validated 100+ DocuSign systems using our methodologies, document templates, and processes. No need to create your documents from scratch. You will get the fully validated DocuSign capabilities – validated for life sciences best practices – and once validated, system configurations can be modified when changes are required via change control processes.
Your patients, investigators, and employees are global – and the processes between them should allow them to complete agreements quickly, easily, and securely - while adhering to regulatory standards.
DocuSign helps organizations connect and automate how life sciences and healthcare industries prepare, sign, act on, and manage agreements. As part of the DocuSign Agreement Cloud, DocuSign offers FDA 21 CFR Part 11 and HIPAA compliant eSignatures—the world’s #1 way to sign electronically on practically any device.
USDM handles your implementation and validation and keeps your systems continuously compliant with Cloud Assurance, a managed service that supports new DocuSign releases, including updated scripts and ongoing automated regression testing.
DocuSign and USDM Life Sciences have an established partnership and draw on expertise from deployments at the top 20 global biopharma and medical device companies as well as high growth life science organizations.
USDM Cloud Assurance + DocuSign Customer Benefit
- Achieve and maintain compliance with DocuSign’s Part 11 solution
- 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
- Authenticate patients, investigators, and employees around the world
- Automatically update systems and trigger processes once an agreement is signed
- Significantly reduce your regulated implementation and validation time while modernizing your System of Agreements
- Harmonize and centralize control
- Maintain continuous cloud compliance and manage new releases
Download the DocuSign + USDM Cloud Assurance partnership overview to learn more
With USDM Cloud Assurance, you can use DocuSign to manage GxP validation. DocuSign can be used for HIPAA compliant signatures and data storage, 21 CFR Part 11 signature handling for FDA compliant signatures, as well as help migrate your data to modern cloud applications.
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