An image of a decorative lock icon representing FDA regulations.

FDA 21 CFR Part 11 & EU Annex 11 Compliant

Dion Label Printing is proud to be registered with the FDA and 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.

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 BY the European Union IN 1992. iT DETAILS THE steps needed to maintain Good Manufacturing Practices (GMP) in relation to electronic records and systems.
An icon of a certificate

GMP helps maintain control over items produced to confirm quality is maintained. Annex 11 and Part 11 compliance are both critical when supplying pharmaceutical and medical customers. 

Requirements for Part 11 and Annex 11

Established Standard Operating Procedures (SOPs)
Computer System Validation
Compliance with Good Manufacturing Practices
System Security

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!