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Arlette Schilter

The Hidden Risks of Poor Data Quality: Low Degree of Digitization in Medical Device Industry

Updated: Nov 25

Poor Data Quality lead to

  1. High time loss for experts in norm interpretation

  2. Very high costs for maintaining traceability

  3. High compliance risk


Data tree

3 Problems of poor data quality and low degree of Digitization in Medical Device Industry

In the world of regulatory compliance, the quality of your data can make or break your business. While many organizations focus on collecting and analyzing vast amounts of data, the real challenge lies in ensuring that the data is relevant, up-to-date, and complete.


Digitization in Medical Device Industry is behind other industries.


Poor data quality not only hinders employee efficiency but can also lead to serious compliance issues and derail project timelines. In this post, we’ll explore three critical data quality problems—irrelevant or incorrect data, outdated data, and incomplete data—and how they can impact your organization. We’ll also discuss how Colabon can help you mitigate these risks by providing high-quality, reliable data.


Problem 1: Irrelevant or Incorrect Data

Regulatory landscapes are complex, with thousands of ISO standards, laws, and guidelines available. However, not all of these are recognized or required by the relevant authorities. Using data based on irrelevant or incorrect standards can lead to significant non-compliance risks. For instance, if your organization follows an outdated ISO standard that is no longer accepted by regulators, your submissions could be rejected, leading to costly delays and potential penalties.

Employees who work with irrelevant data often find themselves spending time aligning their work with inappropriate standards, only to realize later that their efforts were misdirected. This not only wastes valuable time but also results in a need for rework, reducing overall efficiency and delaying projects.


Problem 2: Outdated Data

Regulatory requirements are not static—they evolve over time. What was compliant last year might not meet today’s standards. Using outdated data can lead to severe compliance breaches, as regulations often require the most current information. For example, submitting an environmental impact report based on old data could result in non-compliance penalties.

It’s crucial to continuously monitor and assess the current status of your regulatory data. Understanding how regulations have changed since the data was last evaluated is essential for maintaining compliance. Employees working with outdated data may unknowingly base their decisions on obsolete standards, leading to misaligned efforts and additional work. This can significantly delay project timelines as teams scramble to update their work to meet current regulations.


Problem 3: Incomplete Data

Incomplete data is another common issue that can have serious implications for regulatory compliance. This occurs when essential parts of a document, such as forewords, appendices, or even full sections of laws, are not made available to the experts. Selectively choosing only a few clauses or paragraphs from a legal document can lead to a skewed interpretation and an incomplete understanding of the requirements.

When employees work with incomplete data, they risk making decisions based on an inaccurate or partial understanding of the regulations. This can result in errors that require costly and time-consuming revisions. Incomplete data can also severely impact project timelines, especially if the missing information is discovered late in the process, forcing teams to revisit and redo their work.


Conclusion:

In the high-stakes world of regulatory compliance, ensuring data quality is not just about accuracy; it’s about using the right, current, and complete data. Irrelevant or incorrect data, outdated data, and incomplete data can all lead to non-compliance, inefficiencies, and project delays. These risks can be mitigated by adopting robust data management practices that prioritize the quality and relevance of your data.


Get in touch to improve your Data quality!

At ColabON, we understand the critical importance of data quality in regulatory compliance. Our platform provides relevant, always current data that is aligned with the latest laws and standards. We continuously monitor and update our data to reflect any changes, ensuring that your organization remains compliant. Additionally, we provide complete datasets, including all essential documents and sections, so you have the full picture when making decisions.

Don’t let poor data quality put your compliance at risk. Contact Colabon today to learn how we can help you maintain the highest standards of data quality and keep your projects on track.

This blog post addresses the key issues related to data quality and positions Colabon as the solution provider. It’s designed to engage readers and encourage them to consider Colabon for their data quality needs. Let me know if there’s anything else you’d like to adjust!



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