[Sponsor Spotlight: USDM] Life Sciences: Taking Part 11 eSignature to the Next Level

By Bryan Coddington, VP of Cloud Technology, USDM Life Sciences

DocuSign has been working with global life science companies for years, providing a platform that can hepl these organizations accelerate core processes while adhering to 21 CFR Part 11 eSignature requirements.  USDM has been working with DocuSign customers to validate DocuSign’s Part 11 Module and maintain a validated state with every new release. Life Science customers can upload SOPs, protocol forms, and process change docs, distribute them for signature, and store the completed, Part 11 document in DocuSign with all the needed audit details. This process provides significant cost savings and efficiencies to an industry that has been slowed down by paper and wet signatures.

What’s next? Life science customers accelerate business processes with with DocuSign and USDM by extending DocuSign to work with other cloud applications. Platforms like Salesforce and Documentum can work seamlessly with DocuSign to combine Part 11 eSignature with dozens of GxP processes in qQuality, cClinical, sService, document management, training, and more.  Imagine incorporating eSignature approvals into applications that handle device repair, adverse events, CAPAs, or product recalls. A typical flow would look something like this:

•      A user fills out a form in Salesforce
•      Upon completion, the user clicks a button to send a document for eSignature
•      That document is dynamic and able to use data from the form and determine who needs to sign and in what order
•      The recipient receives the form and can be tasked with filling in information that will come back to Salesforce along with his/her signature
•      The signed document comes back to Salesforce and is not only stored in the records but can trigger additional workflow, alerts, or automation as appropriate

Now that companies have begun their journey with DocuSign’s Part 11 capabilities, it’s time to harness the power of DocuSign’s robust API to integrate with other key clinical and document management systems. USDM can help identify which applications and processes are a good fit and obtain the greatest ROI. Our team provides process optimization, DocuSign development, change management, and validation expertise. Our DocuSign Validation Accelerator Pack subscription provides the updates needed to maintain validation as DocuSign releases new features and enhancements.

For more on how DocuSign and USDM can help extend the use of Part 11 eSignature throughout your organization, please stop by our booth at DocuSign MOMENTUM May 3-4. You can also learn more at USDM.com or at DocuSign.com.

About the Author:

Bryan Coddington is the Vice President of Cloud Technology at USDM Life Sciences.

For almost a decade, Bryan has been a senior executive in the Cloud space with in-depth knowledge of sales, marketing, and service and support processes and best practices, helping companies maximize their investment in cloud-based CRM applications.

Bryan is a hands-on delivery professional with 100+ projects on the Force.com platform including Sales Cloud, Service Cloud, Communities, Mobile, data migration, custom development, and integration. Bryan possess the delivery expertise to deliver successful cloud-technology projects that provide customers significant ROI and high levels of adoption.

Bryan holds four different salesforce.com certifications and is also certified on the ServiceMax platform.