USDM delivered DocuSign, fully validated and compliant, to enable eSignature functionality for employees working remotely due to COVID-19
The customer, Autolus, was able to be up and running in just seven days and maintain business continuity. Further, the complete validation documentation and maintenance of software changes through a Cloud Assurance subscription set Autolus up for future growth and scalability to expand into new use cases while staying in a continuously compliant state.Transitioning an entire life sciences organization to be able to support working from home during the COVID-19 pandemic can be daunting. USDM can help.
- Autolus, a biopharma company at the forefront of cancer treatments
- The company needed a fast solution for eSignature capabilities due to the COVID-19 remote working mandate
- Stakeholders included IT, QA, and the business system owner
- USDM used its expertise from validating 100+ DocuSign systems to rapidly address the customer’s need
- The customer was able to leverage USDM’s validation templates and DocuSign Audit, and understand how best to use DocuSign’s core, out-of-the-box functionality
- USDM reduced the operational qualification (OQ) and performance qualification (PQ) effort by concentrating on medium-risk and high-risk requirements
- USDM worked closely with three Autolus stakeholders to stay committed and hyper-focused on deliverables
- USDM validated DocuSign Part 11 for Autolus and maintains continuous compliance by managing all new updates though USDM’s Cloud Assurance for DocuSign service
The Results
- 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
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