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TEKLYNX CENTRAL CFR

FDA compliant 21 CFR Part 11 label software

 

Often, the need for a single, unified solution to handle label design, approval, printing, and reporting arises when organizations in industries such as healthcare, life sciences, and pharmaceutical, need to comply with regulatory requirements such as FDA 21 CFR Part 11. With the ability to manage supply chain labeling and integrate with ERP and other business systems, TEKLYNX CENTRAL CFR helps you increase operational efficiency.

    • Browser-based printing interface
    • Combines label creation, traceability, and print automation
    • Manage unlimited printers from a single server
    • Label approval module allows you to approve labels with electronic signatures in accordance with FDA 21 CFR Part 11
    • Custom reports show complete document history

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Key Features of TEKLYNX CENTRAL CFR

TEKLYNX CENTRAL CFR OVERVIEW

Regulatory compliance Regulatory compliance
Comply with industry regulations

TEKLYNX CENTRAL CFR helps you address FDA regulatory compliance standards such as 21 CFR Part 11, as well as other labeling requirements. Electronic signatures are linked to relevant records by requiring a user ID and password sign-in to perform all functions.

Increase efficiency Increase efficiency
SAVE TIME

Web-based access eliminates the need for individual workstation installations. By reducing costly system maintenance and software upgrades, you can spend less time managing your barcode label software and more time managing your business.

Reduce errors Reduce errors
Reduce errors & misprints

A customizable user interface reduces errors and misprints, as well as improves brand awareness. Your complex printing process is simplified to a set of steps that is easy for your staff to master. Create separate processes tailored to the needs of each department, business unit, or supplier/vendor.

Traceability Traceability
Ensure security & accuracy

A controlled environment provides the security you need to ensure accuracy. Defined business processes can be enforced at every level, restricting access to only the printers, compliant labels, and tasks a user needs to perform their job.

Security & control Security & control
CONTROL 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.

Electronic signatures Electronic signatures
Record 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.

"By implementing TEKLYNX CENTRAL CFR, we were able to streamline our entire labeling process, on a global level."

- Frank Carranza, Associate Label Engineer, MicroVention

A centralized solution for 21 CFR Part 11 label creation, printing, tracking, and approval

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TEKLYNX CENTRAL CFR Specifications

Operating System

Client:

Windows® 10

Windows® 11

Server:

Windows® Server 2022

Windows® Server 2019

Windows® Server 2016

Windows® Server 2012

Windows® Server Core 2022

Windows® Server Core 2019

Windows® Server Core 2016

All service packs must be installed

Mobile:

iOS 10.2 or higher, 13.3 is recommended. Both iPhone and iPad devices are supported.

Android 8.0, 8.1, 9.0, 10.0. GUI is optimized for mobile phones, tablets are not recommended

 

Note: See the release notes for compatible operating system versions and builds

Virtual Machine Platforms

For VM platform compatibility, click here.

Memory

Client:

4GB or more RAM (8GB recommended - depending on OS and usage)

Server:

4GB or more RAM (8GB recommended - depending on OS and usage)

Hard Disk Space

Client:

Hard drive with at least 1.5 GB of available space

Server:

Hard drive with at least 10 GB of available space

Display

Client:

Minimum: 1024 x 768 - True Color 32 bit

Server:

Minimum: 1366 х 768 - True Color 32 bit

Supporting Software

Client:

Microsoft® .NET Framework 4.8

Any pdf reader (Adobe Acrobat Reader is available with the installation)

Server:

ASP.NET 4.0

IIS 8.0 or greater

Microsoft® .NET Framework 4.8 (provided with the installation)

Any pdf reader (Adobe Acrobat Reader is available with the installation)

Databases (Server)

Microsoft® SQL Server 2012, 2014, 2016, 2017, 2019, 2022 (SQL Server Express is recommended for demo purposes only)

Oracle 12.2 or higher

Browsers

Microsoft Edge 110.0 or higher

Firefox 110.0 or higher

Chrome 110.0 or higher

Additional Requirements

Installation requires full Administrator privileges


NOTE: Specs are based on the current version of TEKLYNX CENTRAL CFR software.

TEKLYNX CENTRAL CFR SUPPORT

TEKLYNX Validation Accelerator Pack (VAP)

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Label printer drivers
CODESOFT Printer Drivers

 

Download the CODESOFT printer drivers you need to run TEKLYNX CENTRAL CFR

CODESOFT PRINTER DRIVERS

Request additional printer licenses for TEKLYNX CENTRAL CFR here

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