Americas (English)

Choose Your Location

Please select your location & language for the best website experience

Products

LABELING SOFTWARE FOR FDA 21 CFR PART 11

LABELING SOFTWARE FOR FDA 21 CFR PART 11

Regulatory compliance through label management

 

  • LABEL ARCHIVE for label Storage & security
    • Multi-stage approval of label designs by reviewers
    • Establish permissions to control access
    • Keep record of changes, comments, revisions, and print history of every label
    LEARN MORE
  • TEKLYNX CENTRAL cfr for Label Management
    • Approve labels with electronic signatures in accordance with FDA 21 CFR Part 11
    • Custom reports show complete document history
    • Combines label creation, traceability, and print automation
    LEARN MORE

Key Features of TEKLYNX CENTRAL CFR

About 21 CFR Part 11

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.

  

TEKLYNX CENTRAL CFR is TEKLYNX' label management solution designed specifically to help organizations comply with FDA 21 CFR Part 11. It enables users to create complex barcodes such as the 2D DataMatrix barcode, Health Industry Bar Code (HIBC), GS1 Databar, and more. Ensure a secure and compliant process by establishing user permissions and applying electronic signatures to your labels throughout their entire lifecycle.

“We have thousands of global installations and know security and access is top of mind for companies.”

- Nick Recht, Enterprise Product Manager, TEKLYNX

Is it Time to Evaluate Your Healthcare Labeling System?

DOWNLOAD GUIDE

TEKLYNX CENTRAL CFR: MicroVention Inc. Improves Efficiency by 50%

READ CASE STUDY

Need help complying with CFR Part 11?

We’re here to help. Please tell us a little more about yourself and we will be in touch to discuss your CFR labeling needs.

Required field
Required field Too long. 250 character limit. Not valid
Required field Too long. 250 character limit. Not valid
Required field
Required field
Required field
Required field Not valid
Required field Not valid
Required field Too long. 250 character limit. Not valid

Required field Too long. 250 character limit. Not valid
Required field
Required field
Required field Too long. 250 character limit. Not valid
Required field