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June 27, 2023


The A-Z glossary of labeling for life sciences

Sarah Hrycyk

Global Marketing Programs Manager - Strategic Markets

The world of regulated label management has its share of highly specialized and technical language. Whether you're new to the field or seeking to expand your knowledge, this glossary serves as a valuable resource with links to additional information. By familiarizing yourself with these terms, you can navigate the specialized language of regulated label management more effectively and stay informed about the latest trends and developments in the life sciences industry. 

  • AIDC (Automatic Identification Data Capture): Refers to the methods of automatically identifying objects, collecting data about them, and entering them directly into computer systems, without human involvement. A common form of AIDC is a barcode. Read more in our Q&A. 

  • Annex VI: Annex 6 is the European guidance system for electronic records and electronic signatures in the pharmaceutical industry and is equivalent to the USA’s FDA 21 CFR part 11. This annex applies to all forms of computerized systems used as part of GMP-regulated activities. Read our blog for more details. 

  • Artwork Management solution: System used for label and packaging artwork design and layout. Usually comprised of illustration, page layout, image manipulation, and PDF editing software. 

  • Barcode: A sequence of bars and spaces that translates data into a machine-readable format. Follow the link for some barcode fun facts. 

  • Cloud labeling solution: A cloud-based/SaaS labeling solution (rather than on-premise), gives companies more flexibility over how they manage their label and content management processes. Loftware is the world’s largest cloud-based Enterprise Labeling and Artwork Management provider, offering an end-to-end labeling solution platform for companies of all sizes. Find out which solution would suit your organization. 

  • Commercial-Off-The-Shelf (COTS): Software that is ready to use without customization, though it can have configurable aspects. 

  • Country specific labeling: Information added to the product packaging that contains information specific to a shipping destination/country of use, not present on the primary product labels.  

  • Decentralized Clinical Trials (DCT): Decentralized trials bring clinical research opportunities to participants where they are (Direct to Parent (DTP)) rather than traditionally bringing participants to central clinical trial sites. This approach aims to improve access to clinical trials and to make it easier for patients to participate in them. Read more. 

  • eIFU: Electronic version of a medical products Instructions for Use (IFU), typically made available on the company product website for viewing/download. 

  • Enterprise Labeling solution: A solution that links labeling processes with business processes to drive speed, accuracy, and compliance. This helps to eliminate the risk of labeling errors, thereby saving companies money, time, and brand reputation. 

  • EU CTR 536/2014: The EU Clinical Trial Regulation (536/2014) replaced the European Clinical Trials Directive (2001/20/EC) in 2022. It includes detailed safety provision assessments, indemnity provisions, and measures to support multi-national clinical trials. 

  • EU MDR: The new EU Medical Devices Regulation (EU MDR) started to come into effect in May 2021, with several major implications for medical device labeling that will extend over the next 5-year period. Watch our latest webinar on the EU MDR and timeline extensions. 

  • FDA 21 CFR Part 11: A regulatory measure allowing medical device and clinical trial organizations to use electronic records and signatures in place of paper-based documentation under certain criteria. Read more. 

  • Good Automated Manufacturing Practice (GAMP) V: A set of principles of procedures to ensure medical products meet required quality standards across every stage of the manufacturing process. 

  • Globally Harmonized System (GHS) of Classification and Labeling of Chemicals: Developed by the United Nations, it is a system of communication for chemical hazards that can be adopted by countries around the world. The guidelines classify the hazards of chemical products (i.e., substances, materials, or mixtures), and hazard communication tools (i.e., format and for safety datasheets and labels with hazard and precautionary statements, symbols, and signal word). 

  • Global Labeling Solution (GLS): a labeling system developed to operate and standardize across multiple territories and regulatory environments.  

  • GS1: The international organization that oversees a system of globally recognized open standards for unique identifiers, such as barcodes that can be used throughout the supply chain to enhance traceability. Read our interview with GS1. 

  • Global Trade Item Number (GTIN): Refers to the data string contained in a barcode that identifies the manufacturer, package level/configuration, product code, and check digit. 

  • GxP: The combined guidelines and regulations in place to ensure pharmaceutical, clinical research, and medical device products adhere to quality processes throughout the product journey. 

  • HIBC - Health Industry Barcode Standard grew out of a task force hosted by the American Hospital Association and composed of numerous other healthcare trade organizations.  

  • Instructions for Use (IFU): Instructions provided with a healthcare product for safe and effective use.  

  • IQ/OQ/PQ: Three key levels of quality checks within pharmaceutical manufacturing. IQ (Installation Qualification) ensures the installation is correct; OQ (Operational Qualification) checks the product or application is working using test data; and PQ (Performance Qualification) establishes that the product or application, under real-life conditions, consistently produces products that meet all predetermined requirements.  

  • Label reconciliation: The process of ensuring all labels issued have been used, destroyed, or removed from the production line to prevent label mix-ups between product lots. 

  • Label validation: The process of checking that the design, content, and printed form of a label convey the intended information. 

  • Label verification: Confirmation that the label is correct and legible during distribution and storage. 

  • Line scanner: Hardware used to scan and capture printed labels for inspection purposes. In the labeling context, it is typically attached to a printer to capture an image immediately after the print head 

  • Master Label Text/Country Label Text (MLT/CLT): The process of managing the wide array of country-specific labels that are required for a multi-national clinical trial. MLT/CLT translation management ensures that all the label information is correctly translated and that the design and other label elements comply with the relevant local regulations. 

  • Unique Device Identifier (UDI): The system to allow the easy recognition of products enabling traceability from manufacturing to distribution to patient use – a key element of regulatory compliance for medical device manufacturers trading in the US and Europe.  

  • Validation: The process of establishing documentary evidence that a procedure, process, or activity carried out in testing and then production maintains the correct level of compliance at all stages.  

  • Vision inspection: Automated system used to verify a printed label to a pre-approved template.  

In conclusion, understanding the terminology and concepts in regulated label management is crucial for businesses operating in industries such as pharmaceuticals, medical devices, and clinical research. By leveraging the information provided in this glossary, you can enhance your knowledge and streamline your label and content management processes. 

However, we understand that implementing and optimizing these practices can be complex. That's where Loftware comes in. As a leader in labeling solutions, we offer cloud-first approaches and industry expertise to help you navigate the intricacies of regulated label management seamlessly. 

To learn more about how Loftware can support your organization's specific needs and find the right labeling solution, please contact us today. 

  • Cloud
  • Regulatory
  • GHS
  • GS1
  • UDI