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.
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.
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.
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Data Governance & Security
Manage roles and permissions to keep your data safe
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Single Sign On
SAML/LDAP authentication - safer integrations across your stack
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Electronic Records & Signatures
Fully compliant with FDA CFR 21 Part 11 and EMA EudraLex Annex 11 (Electronic Records and Signatures)
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Biometric Authentication
Easily and confidently log operator identity at the source
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Digital History Records
A new way of managing the data that matters most including batch records, device records, and equipment logs
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Approval Workflows
Enable efficient review and approval of only required aspects as defined by your business
Simplify compliance.
We built our platform to make compliance a seamless part of operations.
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