By default, your desire to market products in Europe makes EU cybersecurity compliance one of your primary organizational goals. Unfortunately, the path to effective regulatory adherence may be less obvious than you'd hoped: It's essential that you clarify the standards you need to adhere to before implementing a governance solution.
Each organization that pursues compliance faces a unique and on many occasions a complex journey. Fortunately, existing standards development roadmaps provide some clarification about the major issues you should target.
The governance techniques your company employs are totally up to you, and there are many to choose from. Effective information security training focuses on the methodologies that facilitate the most appropriate safeguards.
The governance techniques your company implements must suit you R&D and production environments such that your governance implementation reflects the manner in which you work and in which your company produces its GxP-relevant products.
Where Do Cybersecurity Obligations Originate?
EU cybersecurity plans published in 2013 revealed that regulatory agencies were working to identify and address uniquely European concerns. The changes are ongoing to this day.
At first, some of the targets identified in these documents seem unrelated to GxP organizations. In reality, however, their open-ended nature makes medical device and software manufacturers prime candidates for governance improvement.
For instance, one notable action from the 2013 publication involved the establishment of Computer Emergency Response Teams (CERTs) by EU Member States. The idea behind this plan is to improve national reaction times when cyber-attacks occur, but it could easily impact the private sector too.
Suppose an EKG product line sold to hospitals in Spain was compromised by a nationwide security breach. The CERT that responds might demand rapid backdoor entry into the device manufacturer's product supplier logs or sale records in response.
If the manufacturer fails to incorporate these special provisions and self-diagnostic features, they could be deemed non-compliant. Existing computer systems validation standards, like EU Annex 11, offer further insights into effective governance methods.
Clearing up Misconceptions
The processes by which regulatory guidelines are drafted and ratified can be confusing. For instance, a new EU cybersecurity proposal may carry little weight until it's formally adopted. In the meantime, however, device manufacturers and other regulated companies remain unclear on their responsibilities.
You can't just go by published standards without some understanding of their context. Though useful, these documents are merely the end results of broader-sighted policies that develop over time and impact numerous GxP sub-domains.
Companies that want to address cybersecurity concerns, like regulated cloud-computing policy governance, data validation and trust, may benefit from guidance. At the very least, few industry insiders deny the need for clarification.
What's Coming up Next?
Roadmaps and directive proposals offer a huge wealth of information in the form of targets. These benchmarks don't divulge specific governance techniques, but they give you a good general idea of where you might need to focus.
Now that you know where to look for compliance inspiration, the only problem is achieving parity with changing EU cybersecurity standards. Contact GxP-CC consultants to find out more about your options and the methodologies that best suit your organization.