FDA GMP
EAR
GDPR
ITAR
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
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
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
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