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GxP & Compliance

GxP & Compliance

Tulip’s features and architecture are designed to simplify compliance.
Configuring machine in pharmaceutical manufacturing facility

FDA 21 CFR Part 11 / EU GMP Annex 11

21 CFR Part 11 regulates the use of digital documentation and electronic signatures. With its sibling regulation, EU GMP Annex 11, 21 CFR Part 11 is important for life sciences and medical device industries.

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The International Traffic in Arms Regulations (ITAR) controls the manufacture, sale, and distribution of products and services appearing on the United States Munitions List. EAR applies to dual-use items, which are available both for commercial sales and government use.

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The EU’s General Data Protection Regulation outlines strict protections for consumer data, prioritizing integrity and confidentiality and limiting how organizations can handle data.

  • Data Governance & Security

    Manage roles and permissions to keep your data safe

  • Single Sign On

    SAML/LDAP authentication - safer integrations across your stack

  • Electronic Records & Signatures

    Fully compliant with FDA CFR 21 Part 11 and EMA EudraLex Annex 11 (Electronic Records and Signatures)

  • Biometric Authentication

    Easily and confidently log operator identity at the source

  • Digital History Records

    A new way of managing the data that matters most including batch records, device records, and equipment logs

  • Approval Workflows

    Enable efficient review and approval of only required aspects as defined by your business

  • Option for 0-RPO

    Minimize the risk of lost mission-critical data, such as for eBR and eDHR.

  • Right-the-First-Time eBR & eDHR

    Reduce missing or incorrect information with guidance, verifications.

  • Deploy in hands-free environments

    Use Tulip on wearable headsets in a lab or cleanroom

Simplify compliance.

We built our platform to make compliance a seamless part of operations.

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