— Compliance
Meet and fulfil compliance requirements
21 CFR Part 11
Compliance with U.S. FDA requirements for electronic records and electronic signatures, applicable to pharmaceutical, biotech, and medical device industries.
EU MDR/IVDR (EU) 2017/745
Conformance to EU Medical Device and In Vitro Diagnostic Regulations, covering design, labeling, and traceability for devices sold in the EU.
Falsified Medicines Directive 2001/83/EC
Support for anti-tampering and unique identifier features on prescription drug packaging, ensuring EU supply chain safety.
GS1-128 Data Structures
Encoding of product ID, batch/lot number, expiry date, etc., using GS1-128 barcodes for logistics, healthcare, and retail.
GS1 1D/2D code specifications
Implementation of globally standardized 1D and 2D barcodes (EAN/UPC, DataMatrix, QR Code) across retail, healthcare, food, and logistics.
ISO/IEC 15418 / ANS MH10.8.2
Data structure analysis and compliance for Data Identifiers (DIs) and Application Identifiers (AIs), used in barcode parsing and auto-ID systems.
UDI (Unique Device Identification) for Medical Devices
Full support for UDI systems as required by FDA and EU MDR, enabling medical device traceability from production to patient.
IUID/UID for MIL STD 130N
Compliance with U.S. DoD standard for item unique identification, suitable for defense, aerospace, and government asset tracking.
(EU) 2018/574 Tobacco Regulation
Traceability features meeting EU tobacco product regulation, including unique identifiers and transaction chain recording.