Trade is accelerated by consistency in information exchange. If both parties know when, how, and where money and information will be exchanged, the transaction happens more rapidly.
Product labelling is the universal methodology for information exchange on shipped goods. Consistency in labelling can be achieved by regulatory agencies creating policies, global organizations developing worldwide standards, or even a dominant player taking the lead in dictating standards others adopt as well.
Non-compliance with these standards can result in fines, returned shipments, audits, and additional time spent transporting, receiving, and processing goods. Delays of this sort are not readily accepted in a world already struggling with logistics constraints.
Below is a sampling of the various compliance requirements, and the benefits of TSC Printronix Auto ID printers in generating compliant labels.
Labelling mandates and compliance tend to fall into the following categories:
Serialisation
Ensuring each device has a unique serial number for tracking and, if needed, recall. The objective is to ensure no missing or duplicate serial numbers, and that the serial number clearly marked on the item. Please see our solutions in this area in collaboration with software partners for unique serialization. Examples of serialization regulations include:
Unique Device Identification (UDI) Labeling
The US Food and Drug Administration (FDA) requires that all medical devices distributed in the United States be labelled with a Unique Device Identifier (UDI).
UID (Unique Identification) and Item Unique Identification (IUID) Labeling Compliance
Drug Supply Chain Security Act (DSCSA)
Label Content
These compliance requirements include specifying format, content, barcode symbology, and required elements or symbology on the label. Please see our comprehensive range of printer solutions with a wide range of printer-language emulations and advanced print functions to provide support for a wide range of label sizes, substrates, and data streams. Examples of content regulations include:
Globally Harmonized System (GHS) Labeling
The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was enacted to improve safety and protect the health of workers within the chemical industry.
US Healthcare Label Compliance
European Union Medical Device Regulation (EU MDR) Labeling
GS1 Labeling Compliance
Food Labeling Compliance
Automotive Compliant Labeling
Transportation Industry Compliance
Airline Industry Compliance
Telecommunication Industry Compliance
Retail Industry Compliance
Environmental Labels
Media Specifications
In addition to label content, physical attributes such as label size, substrate, colour, and material may also be mandated by regulatory agencies, industry groups, or industry leaders.
Readability Metrics
A perfectly designed label printed on the compliance material will fail absolutely if the information on the label cannot be read. The American National Standards Institute (ANSI) defined a barcode grading schema adopted by the International Standards Organization (ISO) as ISO-15415 for 2D barcodes and ISO-15416 for 1D barcodes. Regulations or customers not only define label content and material but also minimum ISO grades for barcode readability.
Please read about our solutions for integrated barcode validation and verification. Providing the easiest solution to implement without external scanners, PCs, templates, or operator intervention, every barcode on every label on every job will be found, read, and graded. The grading report is available for archival to defend against chargebacks or fines.
Additional Compliance Resources:
An Introduction to RAIN RFID Numbering Systems for the Pharmaceutical Industry
Understanding ISO-Based RFID Encodings: A Primer from Our RFID Subject Matter Expert
The Essential Guide to Getting Started with Barcode Verification and Validation
How the Cannabis Industry Uses RFID Technology to Cultivate Business Intelligence from Seed to Sale