Address Global Regulations and Requirements

Keeping up with changing regulations is a constant challenge. Loftware’s solutions provide the flexibility you need to be  compliant today – and in the future.

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Meet Compliance and Validation Head-On 

meet compliance head on labeling solutions pharmaceutical

Compliance with global regulations is a moving target. Regulations expand and evolve, requiring your labeling and packaging operations to quickly adapt to new requirements. You need solutions that help address current regulations, such as EU FMD, DSCSA, EU MDR and IVDR, FDA UDI and 21 CFR Part 11while offering you the flexibility to adapt to new or updated rules in the future. Loftware Life Sciences solutions help you address your global regulatory requirements by: 

At the same time, you must validate that the systems you use to create and print labels and packaging work as designed. The time and cost required to validate and re-validate as needed are significant. To save costs and streamline this time-consuming process, Loftware solutions help manage your validation process with a Validation Acceleration Pack (VAP) that provides: 

  • Content-rich templates that can serve as a blueprint for your validation process 
  • Validation plans and summary report templates 
  • A 21 CFR 11 assessment template 
  • A traceability matrix 

Learn More about the Loftware Spectrum VAP