Helping Life Sciences Teams Remain Compliant Through Agreement Digitization

Life sciences organizations are operating in a highly competitive environment. To keep pace with the speed of change and ensure the best chance for long-term success, they need to digitize operations. While organizations have dedicated significant resources to improving the way they securely operate with a global hybrid team, a complete digital transformation of critical processes carries the promise of wide-reaching efficiency and security improvements.

However, the decision to digitize critical aspects of a life sciences organization is difficult to balance against the requirements to maintain tight security controls under stringent regulatory scrutiny. DocuSign wants to help. That’s why we are excited to announce an expanded Life Sciences Module, built to give customers a more efficient digital agreement process without jeopardizing compliance.

Life sciences industry needs streamlined digital agreements to operate efficiently

Some of the most critical aspects of getting a drug or device to market—conducting clinical trials, recruiting participants, engaging healthcare care providers, distributing the drug, procuring supplies, etc.—require extensive approvals and documentation that must withstand the rigor of an audit. Life sciences teams often deal with an incredible volume and variety of agreements, encompassing multiple teams (sales, procurement, R&D, etc.) and workflows that require external signatures. Historically it’s been challenging to create and manage these agreements.

To make things more complicated, each type of document often has its own process. In some cases, legal or executive teams may need to review. In others, unique language may be needed to accommodate parties in different geographies. In every case, organizations need to keep up with ever-changing regulations in the locations where they operate and regularly validate their technology for compliance.

Life sciences agreements pose unique compliance challenges

Given the sensitive nature of the information they handle and the regulatory environment within which they operate, life sciences organizations face a unique set of challenges when it comes to digitizing the agreement process. Life science organizations regulated by the Food and Drug Administration (FDA) are required to follow the Code of Federal Regulations Title 21 Part 11. The term “Part 11” applies to records in electronic form that are created, modified, maintained, archived, retrieved, transmitted or submitted under any records requirements set forth by the FDA regulations/predicate rules. Life science organizations face significant risks and penalties if they are found to be noncompliant.

Announcing an expanded life sciences module 

Life sciences organizations have been compliantly sending, signing and managing digital agreements using DocuSign since 2015. More than 20 years ago, our groundbreaking eSignature technology removed the requirement to sign documents with ink and paper, which allowed teams to collaborate with better reach and efficiency. For example, DKMS reduced the time it takes to move from donor clearance to physician acceptance by 97%. Thermo Fisher accelerated their signature collection process to complete 75% of documents in less than one week.

Today, we’re proud to announce the release of our newly expanded Life Sciences Module. With a focus on easy purchasing and implementation, the module combines the DocuSign CFR Part 11 Module, Validator for Life Sciences and SMS Authentication for Part 11. It’s the next step to meet the needs that come with the changing landscape. It’s designed to add essential functionality for life sciences organizations to keep up with patient expectations and a hybrid workforce without jeopardizing compliance with 21 CFR Part 11 or public health and safety. Here’s an overview of the main features:

• DocuSign Part 11 Module provides availability, security and customizability to enable compliance with regulations domestically and globally. This module is designed to be incorporated into a Part-11-specific closed system solution in which there is electronic communication among multiple parties and system access needs to extend to internal and external parties. This module is critical for any life sciences organization that utilizes electronic records and signatures. 
• Validator for Life Sciences performs quality assurance tests aligned to DocuSign’s release schedule to test against production and demo environments. The Validator for Life Sciences produces downloadable reports to provide evidence of successful completion. It’s an excellent tool to help maximize resources as your team increases digitization efforts and constructs a digital stack with more parts.
• SMS Authentication for Part 11 is a necessary feature if your team plans to expand clinical trials to include remote participants. As pharmaceutical companies expand their trials outside the traditional site environments to include rural areas or remote monitoring—which opens the door for more diverse participants—they need technology to allow those individuals to conveniently participate in trials where they live.

The expanded module with SMS authentication streamlines the signing experience. By authenticating via text messaging, the signer doesn’t have to rely on email. SMS authentication simplifies external Part 11 signatures from clinical trial participants, vendors, suppliers, customers and others since they can authenticate through their mobile device without creating a DocuSign account.

By including the Validator for Life Sciences in the module, customers will regularly have the necessary information to determine if re-executing test scripts is necessary. Additionally, Validator for Life Sciences reduces the burden on quality teams to document and test against DocuSign quarterly product releases.

The new Life Sciences Module is available today. It integrates DocuSign’s leading suite of agreement management solutions and is designed to easily fit into your broader technology stack to simplify 21 CFR Part 11 compliance.

Learn more about how your team can benefit from eSignature for Life Sciences.