FDA 21 CFR Part 11 Label Software

Regulation: FDA 21 CFR Part 11

Industry: Healthcare

FDA 21 CFR Part 11 label softwareFDA 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 has specific FDA 21 CFR Part 11 Label Software, such as TEKLYNX CENTRAL CFR, which are designed specifically to address FDA 21 CFR Part 11 and UDI requirements, by allowing you to create complex barcodes such as the 2D DataMatrix barcode, Health Industry Bar Code (HIBC), GS1 Databar, and more.

TEKLYNX CENTRAL CFR 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.

Request a free demonstration of TEKLYNX CENTRAL CFR today!

Read the case study on how TEKLYNX CENTRAL CFR helped medical device packaging and outsourcing solutions provider, Quality Tech Services (QTS), increase efficiency by 40% and become UDI compliant.

See FDA 21 CFR Part 11 in the Electronic Code of Federal Regulations.