Compliance Center
Regulatory frameworks supported by Abundera Sign, with the technical controls mapped one by one. For the broader security and privacy posture, see the Trust Center.
21 CFR Part 11 (FDA)
Electronic records and signatures for pharma, biotech, medical device, and clinical research. Hash-chained audit trail, RFC 3161 timestamps, AATL-certified HSM-backed signatures, WORM evidence storage.
Read the control mapping →ESIGN Act (15 USC §7001)
Federal US e-signature framework. Two-step consent capture, evidence of intent to be bound, retention guarantees, and the right to withdraw consent are all built into the standard signing flow.
See in Trust Center →UETA
Uniform Electronic Transactions Act, adopted by 49 US states plus DC. Treats electronic records and signatures as equivalent to wet ink for most commercial transactions.
See in Trust Center →eIDAS Advanced (AdES)
EU regulation 910/2014. Today Abundera Sign produces PAdES-LTA Advanced Electronic Signatures with AATL-certified keys. Qualified Electronic Signature (QES) via a Qualified Trust Service Provider is on the roadmap.
Read the article mapping →HIPAA & PHI handling
HIPAA Security Rule §164.312 technical safeguards in place today. Business Associate Agreement and PHI envelope mode (AI path disabled, encryption attestation in the audit trail, breach notification SLA) ship Q3 2026.
Read the safeguard mapping →eIDAS Qualified (QES)
Qualified Electronic Signature via integration with a Qualified Trust Service Provider, plus EUDI Wallet acceptance for high-assurance identity proofing. Required for some EU real estate, employment, and healthcare transactions.
See QES roadmap →SOC 2 Type II / ISO 27001
Operating under SOC 2 Trust Service Criteria controls today. Type II observation window in progress (target Q4 2026). ISO 27001 certification follows (target Q2 2027).
Read the criteria mapping →