From paper to a validated digital process in 18 days
USDM deployed DocuSign's 21 CFR Part 11 compliant e-signature solution to help a global biotech move an arduous, paper-based learning management practice into a compliant digital process. The initial use case was deployed in 18 days and became a highly successful first step on the company's digital transformation journey.
The Challenge
The client is a commercial biotechnology company with approximately $11B in annual revenue and more than 10 therapies commercially available. Its training records lived in a paper-based Learning Management System that forced users to print, sign, and then scan, fax, or email every form.
- Relying on the team to return paper-based, wet-signature training records took days to weeks to complete.
- The manual workflow offered no end-to-end transparency and added unnecessary validation and compliance overhead.
- An existing Salesforce cloud platform provided a foundation to easily add an e-signature solution, but doing it in a regulated GxP environment demanded rigorous data integrity controls.
The Approach
USDM's Cloud Assurance team implemented and validated DocuSign's Part 11 module in 18 days. An integration with Salesforce and the customer's learning management system boosted the impact, creating a connected, compliant, end-to-end digital process with unmatched speed and transparency.
- Replaced a legacy process with a high-impact, high-ROI digital workflow (approximately $50 in savings per signature across hundreds of signatures per month).
- Applied a risk-based computer software assurance mindset to deliver a 77% faster implementation of the CSV program and application validation.
- Delivered end-to-end compliance assurance from USDM, keeping the customer audit-ready throughout.
- Left DocuSign available and easily expandable to other GxP processes, adding value across the organization.
The Results
The new process moved training record submissions from a week to less than a day, with measurable gains across speed, cost, and transformation momentum.
- 80% faster submission of training records.
- $300K in annual productivity savings.
- Digital transformation launched with DocuSign and Salesforce, with a repeatable model for future GxP workflows.
A foundation for continuous compliance
By pairing rapid deployment with built-in validation, USDM turned a single training-records use case into a launchpad for broader digital transformation. The same continuous compliance approach keeps the e-signature solution validated and expandable as the organization digitizes more GxP processes. Contact us to fast-track your own compliant e-signature solution.