GxP Cold Chain Software
Engineered for regulated environments. FDA 21 CFR Part 11, EMA Annex 11 and ALCOA+ data integrity are built into the platform — with thermal IQ/OQ/PQ documentation ready for audit on day one.
Audit-Ready by Design
Validation, signatures and traceability that pass inspections without retrofit work.
21 CFR Part 11
Validated electronic records and signatures with controlled access, audit trails and integrity checks.
EMA Annex 11
Digital signatures, change control and risk-based validation aligned with European GMP expectations.
ALCOA+ Data Integrity
Attributable, legible, contemporaneous, original and accurate records — across the cold chain.
IQ / OQ / PQ Documentation
Thermal IQ, OQ and PQ packs delivered with every deployment for fast qualification.
Regulatory Coverage You Can Defend
Every control you need to satisfy inspectors and quality teams
FDA 21 CFR Part 11 Validation
- Validated electronic records
- Electronic signatures
- Audit trail integrity
- Role-based access control
EMA Annex 11 Digital Signatures
- Signed change control
- Computerized system validation
- Risk-based qualification
- Periodic review support
ALCOA+ Data Integrity
- Attributable & legible records
- Contemporaneous capture
- Original, unaltered data
- Accurate, complete history
Compliance Outcomes
What regulated customers achieve on TrueCold
Take Compliance Off Your Critical Path
Deploy a cold chain platform that arrives validated, signed and ready to inspect.
Get the validation pack