NiceLabel - the professional labeling software
 

Healthcare and Pharmaceutical Label Printing

Index 

  •  Regulation description
        -    Electronic Signatures
        -    Audit Trail for Printing
        -    Audit Trail for Documents
        -    Approval (Records Signing)
  •  NiceLabel Identification Options
  •  Summary
  •  Appendix
        -    Step I - Set up secured access for label design
        -    Step II - Configure security for variable data
        -    Step III - Save printed data to a log file

Summary

No vendor can claim that his or her software products are certified Part 11 compliant. However, a vendor can say that his or her product offers all of the technical control features for 21 CFR Part 11 compliance. Please remember, it is the responsibility of the organization governed by the FDA to implement FDA Regulation 21 CFR Part 11 correctly and consistently.

NiceLabel software helps healthcare organizations and their partners to comply with FDA Regulation 21 CFR Part 11. Using proper design techniques and tools make compliance easy. We believe that implementing the new version of NiceLabel as discussed in this white paper provides enough possibilities for a proper FDA compliance solution.

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