Originally appeared on The Human Readable Blog, by TEKLYNX.
Partner Blog BY: NICK RECHT / TEKLYNX
The medical device sector is one of the most regulated industries, and for a good reason: to keep people safe. When it comes to labeling medical devices or parts, security and traceability measures in your labeling software need to be implemented to ensure patient safety.
In this blog, read how three different medical device companies implemented security and traceability into their labeling process.
Case 1: Automated Label Approval Process
A worldwide distributor of medical and dental supplies experienced inefficiencies in their label approval process that led to wasted time and major delays. Originally, their label approval processed looked like this:
- Someone designs a label and prints out a sample
- The label designer delivers the label print out to the Quality Assurance department
- The label approver in the Quality Assurance department makes edits or changes onto the label, and walks it back to the label designer
- The label designer goes to their computer to make requested changes to the label
- Once changes are made, the label designer brings a new printed version to the label approver
- The label approver approves the label and signs it
- The label approver files the label in a physical folder
This process is long and frustrating, especially if there are multiple changes to the label, or multiple people need to review it. Not only is this manual approval a waste of time, but permanent records of physical labels are difficult to store, take up unnecessary space, and are not secure.
With the help of TEKLYNX, the dental supply company was able to solve their inefficient labeling process by implementing TEKLYNX label traceability and approval software, LABEL ARCHIVE. They were able to cut down their label approval process time by over 75% and instead of having to manually deliver printed label copies for approval, they can now request approval and send the label electronically with a simple click of a button.
Case 2: Compliance with Medical Device Labeling Regulations
The leading designer and developer of upper and lower spinal orthotics in the healthcare industry, Aspen Medical, was interested in finding a solution that could improve its ability to meet the vast and ever-changing medical device compliance standards such as the FDA’s standard 21 CFR Part 11 which requires approvals via electronic signature. FDA 21 CFR part 11 applies to the research, manufacturing, and distribution of medical products, and was established to protect the public health and ensure accuracy of electronic medical records. It also enables organizations to reduce costs by using electronic records in lieu of paper.
With the help of TEKLYNX security and traceability software, Aspen Medical improved their ability to comply with medical device manufacturer labeling regulations. TEKLYNX supplemented Aspen Medical with access to a label approval module that allows for electronic approval while providing the required security and traceability in accordance with FDA CFR Part 11.
Case 3: Label Security within the Medical Device Industry
MicroVention, a world-renowned developer and manufacturer of innovative neuroendovascular technologies, needed to support a global and secure multi-user labeling environment that had over 50 different employees in 4 different facilities that needed access to print labels. While operating in locations such as the United States, Costa Rica, and China, MicroVention’s growing global presence required them to be particularly mindful of potential security and accessibility issues related to the company’s data center.
By enabling a label design and approval process with user controls, MicroVention gained confidence in the security of their labels and entire label process. User controls and permissions are used to separate users based on their role in the labeling process:
- The label designer has access to the label design software where they can edit and design labels. Once the label is drafted, the label designer can submit the label into the approval workflow directly within the software.
- The label approver can find labels that need to be verified in the approval workflow and approve the label or request changes within the software.
- Once a label approved, the print user can access the labels but does not have the ability to edit the label or label template. This ensures only the approved label is being printed for maximum security.
TEKLYNX assisted MicroVention by providing the desired level of data center security throughout their global networks with label security and traceability software. Not only are user privileges controlled with customizable groups so only authorized individuals can use the system, but security and traceability software also records audit trails throughout label life cycles, making MicroVention audit ready.
TEKLYNX Label Security and Traceability Software
LABEL ARCHIVE, TEKLYNX security and traceability software, offers secure approval and label storage for your entire organization. Specifically designed to integrate with CODESOFT barcode label design software, LABEL ARCHIVE’s features follow your label from initial design to approval to final distribution and everything in between, giving your business the ability to comply with any relevant industry standard. LABEL ARCHIVE eliminates manual processes surrounding label design approval and helps minimize user error by only allowing printing of approved labels.
Here are a few advantages of LABEL ARCHIVE:
- Compliance – 21 CFR Part 11 compliance requires security, traceability, and version control. LABEL ARCHIVE provides the functionality you need to meet FDA and other industry standards.
- Approval – Choose labels ready for production & deny those that aren’t. Eliminate errors with LABEL ARCHIVE’s email notification capabilities. When a label is created & submitted, get instant alerts.
- Security – LABEL ARCHIVE allows administrators to easily create and maintain user groups and establish permissions to control access.
- Traceability – The system captures and reports on changes, comments, revisions, and print history for every label in your system.
In highly regulated spaces such as the medical device industry, a secure label process that offers maximum traceability is a must. If you are looking to add more security and traceability to your labeling environment, we are here to help!