GxP & Compliance

At Tulip, we know that compliance is the first and last concern of manufacturers in regulated industries. We built our platform to make compliance a seamless part of the manufacturing process. Tulip’s features and architecture are designed to simplify compliance with the most exacting regulations.

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FDA 21 CFR Part 11 Compliant

FDA GMP

Bureau of Industry and Security EAR Compliant

EAR

GDPR Compliant

GDPR

ITAR Compliant

ITAR

EU GMP compliant

EU GMP

GxP Features

Content and 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 for compliance including batch records, device records, and equipment logs.

Approval Workflows

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

working in a highly regulated environment
FDA 21 CFR Part 11 Compliant
EU GMP compliant

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 manufacturers in life sciences and medical device industries.
If you’re concerned about FDA or EU GMP compliance, Tulip can help with:

  • Easy accessible electronic audit trail for all records
  • Compliant electronic signatures
  • Content and data governance and security
  • Global access rights to manage user permission with or without biometric authentication
  • Digital history records, making it easier to manage the materials necessary for proving compliance and traceability
Bureau of Industry and Security EAR Compliant
ITAR Compliant

ITAR & EAR

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.

If you need to comply with ITAR or EAR, Tulip can help you with:

  • Data and content governance. Managed and secure data storage with AWS GovCloud, Azure Government, or your own private cloud
  • Best-in-class encryption to secure your data in transit and at rest
  • Detailed permission and authentications to control access to the platform
  • Fully auditable record of all manufacturing history
GDPR Compliant

GDPR

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

Tulip simplifies GDPR compliance with:

  • Best-in-class encryption to secure your data in transit and at rest
  • SSO – SAML and LDAP authentication to secure integrations with your existing stack

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