21 CFR Part 11 Compliant Label Software

The Food and Drug Administration (FDA) has issued a Final Rule that requires all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI). September 24, 2016 marks the compliance date for Class III devices required to be labeled with a UDI to bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.

TEKLYNX CENTRAL CFR, TEKLYNX' integrated label management system, combines the proven technology of TEKLYNX label design, printing, and tracking software into a single regulatory solution that helps your organization fall in line with FDA compliance standards such as 21 CFR Part 11 and UDI.

Business Benefits

TEKLYNX CENTRAL CFR helps you address 21 CFR Part 11, FDA regulatory compliance solutions, and other labeling requirements.

Hosted label printing for supplier networks. By enabling out-of-network printing, local printing features allow you to force suppliers and/or vendors to print your internally approved labels.

Improve brand awareness internally and externally. Customize the color scheme of your user interface and add your company’s logo to the print page. Whether it’s an internal resource or a vendor printing from your TEKLYNX CENTRAL instance, your branding is carried through.

Secure Electronic Records, Record Retention, and Retrieval. TEKLYNX CENTRAL CFR creates a centralized server-side activity log.

Records Audit Trails. TEKLYNX CENTRAL CFR tracks the who, what, where, and when for each print job, including specific variable data for each job. Information is tracked throughout a label's life cycle, from creation and modification to deletion.

Electronic Signatures. 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.

Limited Access. 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.

Validated Computer Systems. 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.

The TEKLYNX CENTRAL CFR solution includes:

  • A label designer that can easily design a label using information from a text file or database, or create complex bar codes, 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.

When we are asked what sets TEKLYNX apart from the rest, it comes down to 3 main things: reputation, product innovation, and people. For companies big or small, simple or complex, TEKLYNX has a solution that will fit your needs and grow with you as your complexities evolve.
Operating System
Windows Server 2003 x32/x64 (including R2 edition)
Windows Server 2008 R2 x64
2 Ghz or faster
1 GB of free RAM
Hard Disk Space
Minimum 1.5 Gb of free disk space
Minimum: 800 x 600 High Color
Recommended: 1024 x 768 True Color
Video Card
DirectX 9 or higher
Supporting Software
Microsoft Internet Explorer 7.0 and higher
.NET Framework 3.5 SP1
.NET Framework 4.0
ASP .NET 2.0
IIS 6.0/7.0
SQL Server 2005/2008
Additional Requirements
Serial port if required by printer
DVD drive
What is 21 CFR Part 11?
Title 21 is the portion of the Code of Federal Regulations (CFR) that governs food and drugs within the United States. 21 CFR, as it is commonly known, has nearly 1,500 subparts. One of those, Part 11, is the FDA regulation that imposes certain requirements on a firm when it chooses to make electronic records equivalent to both paper records and handwritten signatures. The intent of the regulation is to ensure that electronic records and computer validation signatures are trustworthy, reliable, and generally equivalent substitutes for paper records and traditional handwritten signatures.
What technology does TEKLYNX CENTRAL CFR use for enterprise label management and printing?
The label design component of TEKLYNX CENTRAL CFR is powered by CODESOFT and the label management module is powered by LABEL ARCHIVE. The browser-based printing interface is powered by LABELNET, while the central print management is powered by SENTINEL.
What languages does CODESOFT support?
CODESOFT's interface supports Arabic, Chinese (Simplified), Chinese (Traditional), Czech, Danish, Dutch, English (United States), Estonian, Finnish, French (France), German, Hebrew, Hungarian, Italian, Japanese, Korean, Latvian, Norwegian, Polish, Portuguese (Portugal), Romanian, Russian, Spanish, Swedish, and Turkish.
Can TEKLYNX CENTRAL CFR help manage the approval of my labels?
Yes. The label management component gives you the ability to create custom approval rules. Users can approve labels from within the label designer or through a web interface.
Can I give specific rights to different users?
Yes, you can configure users to have access to different features in TEKLYNX CENTRAL CFR, as well as configure your system to control user access to labels and printers.
Can my users visually validate labels at print time?
The browser-based printing interface displays a preview of the label directly above the Print button. If variable information is added at print time, the preview is updated to display that information.
Can I prevent users from modifying my label designs and printing unapproved labels?
The label design cannot be modified at print time. TEKLYNX CENTRAL CFR provides authority checks to ensure that only authorized individuals can use the system and/or electronically sign a record.
What reporting options does TEKLYNX CENTRAL CFR offer?
Reports can be created on print history or document modification. The reports can be customized to display the most critical information for your business.
Can I track and report on my print history?
Yes, a Print History report can be generated on the server. The Print History report displays the date/time, printer, and variable information printed on the label. TEKLYNX CENTRAL CFR also logs the user, workstation, product, and work order that are associated with each print job.
How is TEKLYNX CENTRAL CFR licensed?
TEKLYNX CENTRAL CFR is licensed by the number of printers, print users, label design users, and reporting users you need. After you’ve purchased TEKLYNX CENTRAL CFR, you can easily add printers and users as your company grows.
Can I centrally manage all my user licenses and rights for all components of my enterprise labeling system?
Yes, all printers, print users, label design users, and report users are managed on a single server. Authentication can be configured to use TEKLYNX user security or Windows Active Directory.
Do I need to install anything on individual workstations in order to print?
No, the browser based printing interface launches in your Internet Explorer browser, so no separate software installation is needed.
What database does CENTRAL CFR use to store labels and configuration data?
The label and configuration data is stored in a Microsoft SQL database. The data that prints on the label can be queried through any OLE database connection.
Where do I manage my printers?
Printers are installed, configured, and managed on the server, giving you peace of mind that the printer settings won’t be inappropriately adjusted on individual workstations.
Can I print outside the company network?
Yes, when the browser-based printing interface is published on a public domain, users can print to printers connected to their local network. A browser-based user interface allows for label selection and true Internet printing from anywhere in the world!
How do I get a demo or trial version of TEKLYNX CENTRAL CFR?
Contact TEKLYNX sales at (414) 837-4800 or fill out the demo request form.
Pricing is available from our sales department. Contact TEKLYNX sales at (414) 837-4800.