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
• 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

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.