USDM delivered fully validated, compliant DocuSign eSignatures in 7 days to enable remote work during COVID-19
A biopharma company at the forefront of cancer treatments was up and running with DocuSign in just seven days, maintaining business continuity through the pandemic. Complete validation documentation and ongoing management of software changes through a Cloud Assurance subscription set the company up for future growth and scalability — expanding into new use cases while staying in a continuously compliant state. Transitioning an entire life sciences organization to support working from home can be daunting. USDM can help.
The Challenge
When the COVID-19 remote-working mandate took effect, a biopharma company at the forefront of cancer treatments suddenly needed a compliant way to capture electronic signatures — fast. Without it, critical document signing and business continuity were at risk.
- The company needed a rapid eSignature solution to keep operating while employees worked from home.
- Any solution had to meet strict GxP and 21 CFR Part 11 expectations without sacrificing patient safety or compliance.
- Stakeholders spanned IT, QA, and the business system owner — three people who needed to move in lockstep on tight deadlines.
The Approach
USDM drew on its experience validating 100+ DocuSign systems to compress a normally lengthy validation effort into days, using a proven, risk-based methodology.
- The company leveraged USDM's validation templates and DocuSign Audit, and learned how best to use DocuSign's core, out-of-the-box functionality.
- USDM applied a risk-based assurance approach — reducing operational qualification (OQ) and performance qualification (PQ) effort by concentrating on medium-risk and high-risk requirements.
- USDM worked closely with three stakeholders to stay committed and hyper-focused on deliverables.
- USDM validated DocuSign Part 11 and now maintains continuous compliance by managing all new updates through USDM's Cloud Assurance for DocuSign service — so each vendor release stays audit-ready and data integrity is preserved.
The Results
By pairing reusable templates with a focused, risk-based scope, USDM delivered a validated, compliant eSignature capability in a single week — and kept it compliant for the long run.
- 7 days to go live with fully validated, compliant DocuSign eSignatures
- 90% less time to validate
- 50% faster obtaining signatures
- 40% reduction in customer review time
"Our company had to dramatically and immediately change the way we work while still ensuring patient safety and compliance during this global pandemic. Our validation of 21CFR11 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
Built to Scale, Built to Stay Compliant
The seven-day deployment wasn't just a quick fix — the complete validation documentation and Cloud Assurance subscription gave the company a durable foundation to expand into new use cases while remaining continuously compliant. Continuous compliance turned a pandemic-driven scramble into a scalable, audit-ready capability.
Learn how artificial intelligence (AI) helps to improve efficiency and simplify compliance in the electronic signature (eSignature) process in our latest white paper.
Contact USDM today to implement eSignature solutions in less than 10 days.