USDM’s rapid validation and implementation of DocuSign helped a global life sciences company expand their GxP environment for DocuSign in 2 months.
The Challenge
A global pharmaceutical and medical device company needed to expand its use of DocuSign's electronic signature system for global GxP usage. With over 4,000 employees and operations in more than 60 countries, the specialized life sciences company conducts research, development, marketing, and sales of pharmaceuticals and medical devices.
One of the critical challenges facing the company was its need to comply with the FDA's 21 CFR Part 11 regulation for electronic signatures. Furthermore, the company needed to implement additional documentation, such as a Systems Development Plan, to address Japan-specific regulatory requirements above GAMP5. The customer was on a tight timeline and needed a fast turnaround and a cost-effective solution that would not compromise data integrity or audit readiness.
The Approach
USDM provided the customer with a proactive and rapid solution to their validation activities. USDM's team of experts delivered a fully validated DocuSign system, including a Validation Plan, IQ Report, OQ Plan and Report, PQ Plan and Report, a Configuration Sheet, and a final Validation Report.
Each deliverable was built to satisfy 21 CFR Part 11 electronic signature requirements while layering in the Japan-specific documentation needed above GAMP5. USDM applied a risk-based, computer software assurance (CSA) mindset to focus effort where it mattered and keep the program on its compressed timeline.
Built for the cloud update lifecycle
Because of their tight timeline, the customer also needed a reliable and efficient way to manage the ongoing cloud updates to the DocuSign system. USDM Cloud Assurance was structured to keep the validated system compliant as the SaaS vendor pushes new releases — eliminating the recurring scramble that comes with every cloud update.
The Results
With USDM’s validation of the DocuSign electronic signature system, the customer improved the efficiency of its GxP-related processes, allowing them to complete regulatory submissions and other documents more quickly and efficiently. The expanded environment went live in 2 months, on schedule for Go-Live across a footprint spanning more than 60 countries.
USDM helped the customer save time and resources, enabling them to focus on their core mission of developing and producing innovative pharmaceutical and medical device products. Ongoing operational support continues to keep DocuSign in a validated state through every cloud update — a hallmark of continuous compliance.
In our customer’s words
“USDM provided proactive and timely support to guide our global usage extension project for DOCUSIGN in time to Go-Live. Their expertise and experience with DOCUSIGN really made a difference. The operational support provided after Go-Live is also highly beneficial to keep the system in a validated state.” – IT Specialist
“USDM provided high-quality Validation support for DocuSign and collaborative project management. Thanks to USDM’s expertise, DocuSign was validated and is now available for global GxP usage. In addition, the ongoing operational support by USDM is much helpful for us to keep DocuSign appropriately validated. We are glad to have our great collaboration with USDM.” – IT Project Manager
Ready to validate and maintain your own GxP cloud systems? Learn how USDM Cloud Assurance keeps electronic signature and SaaS systems audit-ready, or contact us to accelerate your next validation and Go-Live.