DocuSign GxP Compliance
Sign regulated documentation electronically and improve business continuity with GxP compliance
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! We have validated more than 175 DocuSign systems using our methodologies, document templates, and processes. No need to create your documents from scratch; you will get DocuSign capabilities fully validated for life sciences best practices. Once validated, system configurations can be modified via change control processes.
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. It is the world’s No. 1 way to sign electronically on practically any device.
DocuSign and USDM’s established partnership draws on expertise from deployments at the Top 20 global biopharma and medical device companies, and high-growth life sciences organizations.
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, and migrating your data to modern cloud applications.
Learn how artificial intelligence (AI) helps to improve efficiency and simplify compliance in the electronic signature (eSignature) process in our latest white paper
USDM Cloud Assurance + DocuSign Benefits
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.
- 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 (EU), GDPR (EU), 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
What Our DocuSign GxP Customers Are Saying
“We have worked with USDM on several implementation projects including Box GxP, ComplianceQuest, and most recently DocuSign GxP. The USDM team consistently approaches projects pragmatically and with a high degree of professionalism and enthusiasm. I particularly appreciate that they do not take a ‘one size fits all’ approach, but work collaboratively with all our stakeholders to ensure our business objectives are met. Further, the USDM Cloud Assurance service offering is a key enabler for us being a lean life sciences organization. We look forward to our continued partnership with USDM.”
– Executive Director, IS
“As a small, but global pharma company, we needed a flexible and reliable resource to quickly build up our Part 11 compliant infrastructure. The USDM team provided well-written and complete documentation to support the implementation of DocuSign Lite and delivered on-time execution of the validation activities. They were available for questions and provided timely responses to support the validation of the system. I would recommend their team for any small company that needs knowledgeable external support when implementing a validated instance of DocuSign.”
– Global Pharma Client
“Our company had to dramatically and immediately change the way we work while still ensuring patient safety and compliance during the global pandemic. Our validation of 21 CFR Part 11 DocuSign was completed in an amazingly short amount of time with a high degree of quality by working with the USDM Cloud Assurance team. USDM’s Validation Accelerator Package for DocuSign, coupled with USDM’s experience and knowledge of how the life sciences industry has configured the tool, created a successful implementation.”
– Duane Mixon, Director, IT Service Delivery
Additional DocuSign GxP Resources:
- Case Study: DocuSign in 7 Days to Enable eSignatures for Remote Work
- Case Study: Cloud Assurance for DocuSign Decreases Immunotherapeutic Company’s Validation Costs by 33%
- Case Study: Biotech Completes 70% of eSignatures in 24 Hours
- Case Study: Training Records Completed 80% Faster (DocuSign + Salesforce)
- Video: DocuSign Part 11 Compliance: Electronic Signatures
- Blog: USDM’s Guide to 21 CFR Part 11 Compliance
- Webinar: Update from the FDA on CSV Changes