MicroVention, a world-renowned developer, manufacturer and marketer of neuroendovascular technologies, had previously leveraged TEKLYNX’ barcode label design solution, LABELVIEW to design and print labels. However, MicroVention was experiencing rapid growth, fueled by growing product demand and expanded distribution in key international markets.
The Tech Decision
MicroVention’s Associate Label Engineer Frank Carranza contacted TEKLYNX’ Enterprise Product Manager Nick Recht because the medical device manufacturer reached a point where it needed a labeling solution that was available over its network as opposed to a system that was stored on each individual computer.
TEKLYNX collaborated with MicroVention to determine that browser-based, integrated enterprise label management solution TEKLYNX CENTRAL CFR would be a scalable and efficient solution for managing MicroVention’s facilities, including those beyond US borders, while providing the bandwidth for future growth. As companies grow and business requirements change, so do labeling requirements. The upgrade to TEKLYNX CENTRAL CFR was an opportunity for MicroVention to streamline labeling operations globally.
MicroVention’s implementation of TEKLYNX CENTRAL CFR took approximately one year from start to finish. During this time, MicroVention relied on TEKLYNX for valuable advanced label creation services to meet MicroVention’s unique business needs. These services proved invaluable as MicroVention relied on TEKLYNX to convert existing labels and adjust VBScripts. TEKLYNX also created extensive logical date stamp formulas to ensure accurate printing of expiration/manufacturing dates on MicroVention’s products.
MicroVention integrated TEKLYNX CENTRAL CFR with its existing JD Edwards ERP system, streamlining labeling processes while addressing critical needs.
TEKLYNX CENTRAL CFR is a browser-based, integrated label management system that combines the proven technology of TEKLYNX label design, print automation and tracking software into a single regulatory solution that helps companies fall in line with FDA compliance standards such as 21 CFR Part 11 and Unique Device Identification (UDI).
TEKLYNX CENTRAL CFR features:
- A label designer that can easily design a label using information from a text file or database, or create complex barcodes, such as HIBC or GS1 Databar, to meet FDA compliance and Healthcare and Pharmaceutical industry standards.
- A label approval module that allows you to approve label designs with electronic signatures while providing the required security and traceability in accordance with FDA 21 CFR Part 11.
- An automated network printing module that can manage hundreds of printers in multiple locations from a single server.
- Custom reporting options that provide complete document history and activity logs for traceability.
- A browser-based user interface for label selection and true Internet printing from anywhere in the world.
- A single regulatory compliance software Command Center that coordinates your enterprise labeling process while providing secure access and sophisticated user profile control.
TEKLYNX CENTRAL CFR business benefits:
- Hosted label printing for supplier networks. By enabling out-of-network printing, local printing features allow companies to force suppliers and/or vendors to print internally approved labels.
- Companies can customize the color scheme of its user interface and add its logo to the print page to improve brand awareness internally and externally.
- TEKLYNX CENTRAL CFR creates a centralized server-side activity log to secure electronic records and enable record retention and retrieval.
- TEKLYNX CENTRAL CFR tracks the who, what, where, and when for each print job, including specific variable data for each job to create audit trails.
- TEKLYNX CENTRAL CFR regulatory compliance software ensures that electronic signatures are linked to relevant electronic records by requiring User ID and password sign-in to perform all functions.
- TEKLYNX CENTRAL CFR provides authority checks to ensure that only authorized individuals can use the system and/or electronically sign a record. User privileges are controlled by customizable user groups, password expiration, and failed login tracking, all managed with Windows Active Directory.
- TEKLYNX CENTRAL CFR offers 3 years of support after a major version release, providing a stable system that will avoid the cost and time spent on re-validation.
TEKLYNX also created upload SQL scripts for all label design and product associations to improve MicroVention’s database speed and efficiency, a move that made it easier for network users in Costa Rica and China to utilize the system. In addition, TEKLYNX created interface patches to further customize MicroVention’s user interface. This customization slimmed down MicroVention’s interface, allowing for greater ease-of-use and faster network speed. All told, these custom development services were key to helping MicroVention not only label better, but also work better as a company.
MicroVention benefited from partnering with TEKLYNX because the barcode software solutions provider was able to provide a significant amount of advanced label creation services throughout the implementation process. These services proved invaluable as MicroVention relied on TEKLYNX to convert existing labels and adjust VBScripts. TEKLYNX also created extensive logical date stamp
formulas to ensure accurate printing of expiration/manufacturing dates on MicroVention’s products.
In addition to a 50% improvement in total production efficiency, MicroVention’s successful implementation of TEKLYNX CENTRAL CFR led to the following labeling environment enhancements:
- Improved ability to support its global multi-user, multi-facility environment:
- Access to True Internet Printing allows MicroVention to print labels from anywhere in the world.
- Ability to print labels from up to 1,000 printers provides the necessary bandwidth to support future growth.
Improved ability to support its leanly staffed labeling environment:
- The automated network printing module can manage hundreds of printers in multiple locations from a single server.
- The regulatory compliance software ensures that electronic signatures are linked to relevant electronic records by requiring User ID and password sign-in to perform all functions.
Provided the desired level of data center security throughout its global network:
- User privileges are controlled with customizable user groups so only authorized individuals can use its system and/or electronically sign a record.
- The system records audit trails throughout label life cycles, making MicroVention audit ready.
Improved ability to comply with medical device manufacturer labeling regulations:
- It can now easily create complex bar codes, such as HIBC or GS1 Databar, to meet FDA compliance and Healthcare industry standards.
- It now has access to a label approval module that allows for electronic approval while providing the required security and traceability in accordance with FDA 21 CFR Part 11.
- It now has a single regulatory compliance software Command Center that coordinates its enterprise labeling process while providing secure access and sophisticated user profile control.
In addition to addressing all of MicroVention’s immediate labeling challenges, the TEKLYNX CENTRAL CFR implementation has also put MicroVention in a solid position to address future labeling challenges. This couldn’t be more critical for MicroVention as it looks to continue growth in a highly competitive, fast-growing and ever changing industry.