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Docusign for Life Sciences

Operate more efficiently while meeting your compliance requirements

Get support to handle the ever-changing regulatory landscape in life sciences.

Digitize and connect your entire agreement process with Docusign to increase efficiency and productivity, get to market faster and keep your business moving forward.

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Advance your goals

  • Avoid issues with 21 CFR Part 11 compliance

    Simplify contracts, approvals and agreements while reducing regulatory risk. Life sciences organisations have been ensuring digital agreement compliance with Docusign since 2015.

  • Get medicines and devices to market faster without compromising quality

    Streamline your processes to accelerate product development and commercialisation for medicines and devices.

  • Enhance your customer experience

    Improve interaction with patients, doctors, researchers and vendors by enabling them to complete agreements in an accessible, secure way.

Two scientists work with plants, and one of them has a tablet to manage agreements with Docusign.

How you can use Docusign

From onboarding investigators to sales agreements, you can do business faster with less risk, lower costs and better experiences for patients, doctors, partners and employees.

Meet the needs of the changing life sciences landscape with our purpose-built bundle of products for our life sciences customers.

  • Research and clinical development
    • Preclinical and clinical development

    • Clinical trial enrolment

    • Regulatory submissions

    • Investigator onboarding and site initiation

  • Manufacturing and quality
    • GxP document management

    • SOPs, batch records and more

    • Supplier qualification and onboarding

    • CMO and Technology Transfer Agreements

  • Commercial effectiveness
    • Sales contracting

    • Market access agreements

    • HCP engagement and speaker programmes

    • Patient assistance and reimbursement

Ready to modernise your processes?

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A notification in Docusign eSignature prompts a user to sign an agreement. eSignature is part of our life sciences module.

Life sciences module: boost efficiency and support compliance

Support your compliance with the electronic signature practices set forth in the U.S. FDA's 21 CFR Part 11 and the MHRA's GxP Data Integrity Guidance.

Our life sciences module has three components: eSignature, SMS authentication and validation reports.

Additional Docusign capabilities for life sciences

  • Docusign IAM

    Turn static agreements into dynamic, data-rich assets. AI-powered search and insights help you uncover opportunities while automated workflows help you save time and streamline your entire agreement process.

    Learn more
  • eSignature

    Securely send and sign agreements from virtually anywhere and any device while maintaining a detailed audit trail.

  • Identify

    Remotely verify signatory identity for your important agreements.

  • CLM

    Accelerate contracting with tools supporting document generation, negotiation, storage and analytics.

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Extend the impact of your digital investment with digital workflows, authentication and e-signatures with Docusign integrations for systems you already use.

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Simplify 21 CFR Part 11 Compliance Documentation

Learn how Docusign supports life sciences organisations’ compliance with the e-signature practices set out in 21 CFR Part 11.

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Partner brief

Docusign and USDM Life Sciences

USDM provides business process, implementation and validation services for Docusign customers in life sciences.

Docusign for life sciences FAQs

  • In the life sciences industry, electronic signatures are used to streamline agreements. Pharmaceutical organisations use e-signatures for clinical trial enrolment, supplier contracts and more to accelerate the development and delivery of therapeutics to market. Medical device manufacturers use e-signatures for clinical testing, sales contracts, service agreements and more to accelerate product development and commercialisation.

  • Docusign eSignature was the first e-signature tool to enable compliance with FDA 21 CFR Part 11. Recently, to meet the needs of our life sciences customers without jeopardising compliance, we released a new package of features. The Life Sciences Pro package includes Part 11-specific eSignature functionality, Validator for Life Sciences and SMS authentication. In the same way that Docusign was the first to offer Part 11 compliance, we’re the first to bundle features like this together for our life sciences customers.

    The Life Sciences Module provides a high-availability, high-security and highly customisable solution to maintain compliance with regulations domestically and globally. The module is designed to be incorporated as part of an open system solution, where electronic communication occurs among multiple parties and system access must extend to both internal and external parties. This module is absolutely critical for any life sciences organisation that handles electronic records.

    Learn More About Docusign Life Sciences Modules for 21 CFR Part 11

  • Docusign IAM empowers life sciences organisations to transform agreements from bottlenecks to strategic drivers across the entire value chain, accelerating the journey of life-saving therapeutics from R&D into manufacturing and through commercialisation. By leveraging a single, extensible platform to manage all end-to-end agreement processes with unparalleled scale and trust, life sciences organisations see a 40% reduction in personnel time per agreement, a 19% reduction in compliance incidents and a 95% improvement in data quality. Our unmatched ecosystem of 1,000+ integrations and robust APIs enables life sciences organisations to reduce risk, maintain compliance with evolving regulations and, ultimately, unleash the power of their agreements for growth, innovation and efficiency.

Experience it for yourself

Make your business faster, simpler and more cost efficient with electronic agreements.

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Our teams will be happy to help you find the perfect fit of products and solutions.