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21 CFR Compliance


TEKLYNX


TEKLYNX 21 CFR Compliance


21 CFR Compliance Patient Admittance Point of Care
Blood Bag ID HL7 Wristband Printing Healthcare main

Meeting 21 CFR compliance requirements for a labeling system means providing limited access, electronic signatures, complete electronic records and version control of label design templates.

Solution
LABEL ARCHIVE is a complete security and traceability layer for the label design and printing process. A true server/client approach to label storage provides security, password protected access, complete version control and design approval with electronic signature for your label designs. LABEL ARCHIVE handles many of the requirements to meet 21 CFR compliance.

  • Version Control
    Each label is versioned automatically and in-use labels must be versioned just to edit
  • Security
    Centralized label repository and user/user group security with true "check-in" and "check-out" of label files
  • Approval Process
    Label design changes must be authorized and approved based on your business rules

TEKLYNX Products


User Level LABEL ARCHIVE Client is installed at every design & printing station.
Server Level LABEL ARCHIVE Server is set up by IT. This level controls users and global settings, archives, data, and administers three control levels.

Users login to the system and access a centralized label repository managed by LABEL ARCHIVE Server.

 

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