TEKLYNX CENTRAL CFR

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, 2018 marks the compliance date for Class I and II devices to be labeled with a UDI and for Class II devices 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.

TEKLYNX CENTRAL CFR 5.0 Has Arrived

TEKLYNX CENTRAL 5.0 offers more flexibility than ever before. Built to upgrade, TEKLYNX CENTRAL 5.0 checks
your existing database structure to ensure the installation process goes smoothly. Set up multiple printing interfaces, each tailored to meet the needs of different users. Install the new mobile app and print labels on the go. Sort through existing labels quickly with system-generated metadata and user-generated tags. Watch our short video to learn all the exciting enhancements in TEKLYNX CENTRAL 5.0!

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 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 5.0 Has Arrived

TEKLYNX CENTRAL 5.0 offers more flexibility than ever before. Built to upgrade, TEKLYNX CENTRAL 5.0 checks
your existing database structure to ensure the installation process goes smoothly. Set up multiple printing interfaces, each tailored to meet the needs of different users. Install the new mobile app and print labels on the go. Sort through existing labels quickly with system-generated metadata and user-generated tags. Watch our short video to learn all the exciting enhancements in TEKLYNX CENTRAL 5.0!
Operating System
Server:
Windows Server 2008 SP2 (x64)
Windows Server 2008 R2
Windows Server 2012/2012 R2
Windows Server 2016
All service packs must be installed

Client:
Windows 7 SP1 (x32/x64)
Windows 8/8.1 (x32/x64)
Windows 10 (x32/x64)

Mobile:
iOS 10.2 or higher. iPhone devices are supported.
Android 6.0, 7.0, 7.1. GUI is optimized for mobile phones, tablets are not recommended
Memory
Server:
8 GB RAM recommended

Client:
2 GB RAM recommended
Hard Disk Space
Server:
Hard drive with at least 10 GB of available space

Client:
Hard drive with at least 1.5 GB of available space
Display
Server:
Minimum: 1366 x 768 - True Color 32 bit

Client:
Minimum: 1024 x 768 - True Color 32 bit
Supporting Software
Server:
Internet Explorer 11, Microsoft Edge, Firefox 58.0 or greater, Google Chrome 63.0 or greater
ASP.NET 4.0
IIS 7.0 or greater
Microsoft® .Net Framework 3.5 SP1,
Microsoft® .Net Framework 4.5.2
SQL Server 2008/2008R2/2012/2014/2016/2017 (SQL Server Express is recommended for demo purposes only)
Oracle 11.2 or higher
Client:
Internet Explorer 11, Microsoft Edge, Firefox 58.0 or greater, Google Chrome 63.0 or greater
Microsoft® .Net Framework 4.5.2
Adobe Acrobat Reader 9.0 or greater
Additional Requirements
Installation requires Administrator privileges
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.
What does TEKLYNX CENTRAL CFR cost?
Pricing is available from our sales department. Contact TEKLYNX sales at (414) 837-4800.