Label Security & Traceability

Maintaining a label audit trail is required in certain industries. The FDA 21 Code of Federal Regulations (CFR) Part 11 labeling regulation requires medical device manufacturers and pharmaceutical companies to maintain records of their labeling process. E-signature, a feature of labeling audit trail software, is required for accountability and security.

For the food & beverage industry, while label audit trails are not required by any federal regulation, labeling accuracy is crucial. Other regulations and initiatives such as the Food Safety Modernization Act (FSMA), Food Allergen Labeling and Consumer Protection Act (FALCPA), and Produce Traceability Initiative (PTI) are in place to promote the safety of the food supply chain. Food & beverage companies can maximize their protection against labeling errors by taking advantage of a label audit trail.

Other industries, such as chemical, aerospace & defense, and cannabis, have similar safety labeling requirements. While a label audit trail is not strictly required, the benefits of having one in place are highly valued by companies in these industries.

Whether your company operates in a highly regulated industry or not, it is important to consider implementing a label audit trail to quickly identify and fix labeling errors before they have a big impact on production.

Administrators create and maintain user roles and establish permissions to control access. User roles add that extra layer of security and visibility by capturing who accessed a label, what edits they made, and where and when a label was printed. Users can be limited to print-only users, designers, or approvers, and they can be assigned to different departments like IT, quality assurance, or production, creating accountability at every stage.

Windows Active Directory password protection offers another layer of protection for your labeling environment by dictating rules for creating and managing user passwords within LABEL ARCHIVE.

LABEL ARCHIVE offers a central repository for you to store and archive all your label templates. This repository can only be accessed with a password, so only specific users can see or make edits within the software. Having secure label files helps guarantee no labels will get wrongly edited or printed. If a problem arises, administrators can see a full history of who did what, identifying and fixing the mistake.

No, not unless you want them to edit your labels. With LABEL ARCHIVE you can assign specific user roles and permissions to ensure only authorized personnel can design, print, and approve labels. For example, the design staff creates the labels, management reviews and approves the labels, and production staff prints the labels. The permissions are set by an administrator and can only be changed by them.

Implementing a robust label security and traceability system like LABEL ARCHIVE helps ensure no bad label gets out onto the production floor. LABEL ARCHIVE's version history provides a resource for users to pinpoint what change or error was made, so when a recall occurs, users can go straight to the source and fix the issue. Inaccurate labels lead to recalls or chargebacks, which can result in fines or non-compliance and impact relationships between distributors and retailers or brands and consumers.

• Traceability involves following an item's path backwards from its current point to its origin. LABEL ARCHIVE enhances label traceability by securing your labeling processes which also supports product traceability. It captures and reports changes, comments, revisions, and print history for every product label in your system, but cannot specifically locate the product's position.
• Tracking is following an item or product from the origin to its destination.
• Identification is the foundation behind tracking and traceability. Identification is the process of marking a product with a tag, label, or barcode to distinguish it from other products.

Yes. LABEL ARCHIVE can be added to CODESOFT barcode label design software.

If you are not using TEKLYNX software, you can easily make the transition to TEKLYNX. We offer professional services that help with implementation, custom label design, training, and more to help get you up and running. When you partner with TEKLYNX it's certain that you will be in good hands.