Datasheet
Life Sciences Module

Increase Efficiency and Simplify Compliancewith DocuSign’s Life Sciences Module
To keep up with the speed and complexity of the modern agreement landscape,pharmaceutical, medical technology, biotechnology and other life sciences professionals
need to make a digital transformation. DocuSign wants to help. That’s why we built
a product specifically for the industry: the Life Sciences Module.
This offering is the next chapter in DocuSign’s history of building technology toaccelerate innovation in the life sciences industry. More than 20 years ago, ourgroundbreaking eSignature technology allowed teams to collaborate with better reachand efficiency. In 2015, DocuSign offered the first e-signature application that enables
21 CFR Part 11 compliance, introduced as part of our dedicated Life Sciences package.
Today, the Life Sciences Module will help teams expand their digital agreement
workflows without introducing new compliance risk.
DocuSign’s Life Sciences Module has three components:– An eSignature solution that enables compliance with the FDA’s 21 CFRPart 11 and Annex 11 regulation– A validation solution that streamlines ongoing validation requirements
to adhere to GxP– Ability to authenticate signer identity via SMS text message in addition
to email-based verification

Comply with the FDA’s 21 CFR Part 11 requirements
and GxP standards
The Life Sciences Module provides availability, security and customizability to enable
compliance with life sciences regulations domestically and globally. The eSignaturefunctionality offers prepackaged account configuration for regulatory requirements
without manual setup, which reduces the risk of noncompliance. It’s a critical component
for any life sciences organization that utilizes electronic records and signatures.
DocuSign offers world-class security and protection, with customization options
to meet the needs of any team’s signature process and accommodate the necessaryparties. Life sciences organizations can use DocuSign to build an integrated agreement
process with centralized administrative control. It offers internal and external signers
a seamless signing experience while maximizing administrative visibility, transparency
and auditability.

“DocuSign quickly
became our mosttrusted technology
platform that is
now used in over
80 countries in justtwo years. DocuSign
continues to be asolution to meet
our ambitious goals
so that we canfocus on achieving
what matters to us
most—improving
the lives ofour patients.”
Boehringer Ingelheim
Associate Director
Global eSignature Solution

DocuSign customer results
DKMS reduced the time it takes
to move from donor clearance tophysician acceptance by

97%
Thermo Fisher can complete

75%

of envelopes in less than one weekDocuSign

Datasheet: Life Sciences Module

Improve the signer experience
Signer authentication is necessary to enable 21 CFR Part 11 compliance, but theprocess can be a hurdle or even a dealbreaker for some signers. Traditional methods toauthenticate a recipient’s identity are through email or SSO. In addition to these methods,
the Life Sciences Module now incorporates recipient authentication via SMS text
messaging in compliance with 21 CFR Part 11 requirements. Our mobile-friendly experiencevalidates a signer’s identity with a simple two-factor authentication process that sends
a one-time code via SMS.
Life sciences organizations can choose to authenticate after each signature tag or
while accessing and finishing a session. Signers aren’t required to create an accountto authenticate, so the entire process can be completed with a few clicks. SMS
authentication is a critical tool for teams that want to expand clinical trials beyond
traditional environments to include more diverse remote participants.

Streamline validation testing and documentation
The Life Sciences Module includes functionality that performs quality assurance (QA)
tests on a sample CFR Part 11 DocuSign account aligned to our release schedule to test
against production and demo environments. Our Life Sciences Module produces monthly
automated downloadable reports to provide evidence of successful completion of these
QA tests. Those reports are sent to your team, including screenshots of each test
and details of the specific provisions tested so you have all the necessary
validation documentation.
Below are examples of what a summary report and a specific test will look like. If you want
to receive a sample report, contact your account executive.

Customers use DocuSign
to complete a range of life
sciences agreements
Discovery
Sponsored research
Investigator-initiated researchLaboratory results
Drug Development
Preclinical development
Clinical trials
Patient consent and enrollment
Site initiation
Regulatory submissions
Manufacturing
Batch recordsSOPs
Quality agreements
Safety inspections
Recall notifications
Distribution
Partnership and distribution programs
Vendor/supplier contracts
Agency approvals
Sales and Marketing
HCP speaker agreements
HCP sponsor agreements
Order processing
Sample tracking
Sales agreements

Get more information about the Life Sciences Module or talk to oneof our experts to learn about how DocuSign can help your team.

About DocuSign
DocuSign helps organizations connect and automate how they navigate their systems of agreement. As part of its industry-leading
product lineup, DocuSign offers eSignature, the world’s #1 way to sign electronically on practically any device, from almost anywhere,
at any time. Today, over a million customers and more than a billion users in over 180 countries use the DocuSign platform toaccelerate the process of doing business and simplify people’s lives.

DocuSign, Inc.
221 Main Street, Suite 1550
San Francisco, CA 94105
docusign.com

For more information
sales@docusign.com+1-877-720-2040