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Are You Ready to Become Compliant With EU Annex 11?

October 8th, 2014 by Zuhdi Hussein

EU Annex 11ComplianceIf you engage in GMP-regulated actions, use computers in any facility and wish to market your products in the EU, you'll need to become familiar with EU Annex 11 first. This vital EudraLex Annex pertains to all computerized systems employed in the manufacturing and production of medical products for human or veterinary use, so it's a good chance that your operations fall under its auspices. 

What Changes Must Be Made?

The operational modifications you'll need to implement to bring your IT security systems into alignment with Annex 11 may be beyond the scope of your corporate capabilities as they stand. For instance, some firms find it necessary to tweak third-party software or restructure their networks to make them compliant.

Before you can implement any effective changes, you'll have to get a firm handle on where you are in relation to where your company needs to be.

Charting Your Strategy

Consider the sheer scope of Annex 11. For example, the document states that computerized systems that exchange data with other systems electronically need to incorporate built-in checks that minimize the risks associated with data processing and secure entry. Such mandates seem simple at first, but their practical complexities are nothing to scoff at.

With modern, cloud-connected, highly-networked computer systems, such a stipulation could easily apply to every piece of electronics controlled by a computerized device, or which is assisted in its function by a computer in your facility. But devices like the personal laptops and smartphones your employees use to check on supply chain variables probably don't include such allowances by default. While you can always implement compliance checks after the fact, you must be sure to do so in a manner that actually meets EudraLex guidelines and keeps your costs down.

Even with the best intentions, you may simply lack sufficient knowledge of EU Annex 11 to effectively validate your computer systems.

The Complete Approach to EU Annex 11 Compliance

Also bear in mind that many of the requirements of EU Annex 11 will necessitate changes that impact more than just your computer systems. According to the Annex, some organizational usage procedures, such as modifying certification and batch release data, can only be performed by Qualified Persons. To comply with this stipulation, you may have to engage in additional workforce training or implement completely novel electronic signature procedures. As this very basic example demonstrates, the factors that go into CSV compliance aren't always straightforward or simple. 

The first step in determining your organization's readiness to adopt EU Annex 11 standards is to learn how the rules apply to your operations. Depending on the specifics of how your firm conducts its business, you may only need to focus on limited sections of the Annex. However, in some instances, you'll want to pour over the entire requirement with a fine-toothed comb to determine your responsibilities. In either case, working with industry compliance consultants is a good way to get started off right. 

GxP-CC aren’t just experts on Annex 11, they also have ample real-world experience in helping GMP organizations around the world adapt to its regulatory nuances. Discover more by contacting them today. 


Posted in CSV, EU Annex 11, EudraLex Guidelines, FDA & European Regulations, GMP, GxP CC

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Zuhdi Hussein

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