FDA 21 CFR Part 11 & EU Annex 11 Compliant

Dion Label Printing is proud to be compliant with both FDA 21 CFR Part 11 and EU Annex 11. Part 11 was established in 1997 by the Food and Drug Administration (FDA) to regulate security of electronic records. If a company wishes to continue use of their electronic systems, they must maintain compliance. Originally, the law was established for pharmaceutical, medical and similar FDA regulated biotech companies. Since implementation, the law has expanded to include suppliers for these industries.

EU Annex 11 was established in 1992 through the European Union that details the steps needed to maintain Good Manufacturing Practices (GMP) in relation to electronic records and systems. GMP helps maintain control over items produced to confirm quality is maintained. The law ties directly into Part 11 as quality and compliance is especially necessary in pharmaceutical and medical companies.

Requirements for Part 11 and Annex 11:

  • Established Standard Operating Procedures (SOP’s)
  • Computer System Validations
  • System Security
  • Compliant with Good Manufacturing Practices

Questions on Part 11 or Annex 11 compliance? In need of a label printer who is compliant with both laws? Contact us today for more information!