Beyond the Label: Part 11 and Annex 11

Gina Lisella • Oct 25, 2018
FDA Security

We’ve been talking a lot recently in our blogs about the ways in which we are exceptionally capable of providing pharmaceutical and other industries with the security and safety options they need on their labels (see Beyond the Label: GMI Certification). The fact that we are compliant to FDA Title 21 CFR Part 11 and the EU’s EMEA Annex 11 demonstrates another yet way that we are equipped to handle every aspect of a company’s packaging needs.

While the names FDA Part 11 and EU Annex 11 may sound like jargon, the concepts that they cover are relatively simple. Part 11 was established in 1997 by the FDA as a measure to regulate the security of electronic records and documents. It was originally created for pharmaceutical, medical, and other biotech companies under the purview of the FDA, but has since been expanded to include suppliers for these industries (like us!). Annex 11 was established in 1992 by the European Union. Like Part 11, it lays out the appropriate steps to maintain Good Manufacturing Practices (GMP) with regard to electronic records and systems, but Annex 11 gives more specific guidance in areas not covered in Part 11 regulations. Both Part 11 and Annex 11 are critical for supplying pharmaceutical and medical companies in a safe way, and we are proud to be complaint with both.

There are a number of requirements we follow to maintain compliance with these rules. All of our departments have established standard operating procedures (SOPs) to ensure that everyone at Dion is participating in best practices for electronic security. We are also compliant with the Good Manufacturing Practices laid out in Annex 11. Two other requirements of these laws are computer system validation and system security, particularly with regard to electronic signatures and electronic documents. These measures allow our pharmaceutical, medical, and other clients to rest assured that their digital data is always safe in our hands.

If you’re curious about the other ways we can provide security for OTC pharmaceutical packaging, check out our blog on the topic. Read more here if you have further questions on Part 11 or Annex 11 compliance, and if you’re in need of a label printer who is complaint with both laws, contact us today!

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