Digitalisation in sectors such as pharma, biotech, manufacturing and engineering has long since ceased to be a trend – it is reality. We make data-driven decisions, steer processes through digital tools and rely on automated systems for manufacturing, quality control and documentation. But... how sure are you that the data is accurate, complete and reliable, from start to finish? And what are the risks if that's not the case?

Nathalie Wellens, Data Integrity Advisor with eight years' experience, knows better than anyone why data integrity is crucial to any organisation today. From her role at Pauwels Consulting, she supports companies in structurally anchoring data quality and compliance. She explains why the topic is more relevant than ever – and why you still need to work on it today.

What exactly is data integrity?

According to Nathalie, data integrity is about ensuring that data is complete, accurate and consistent at any point in the data lifecycle. This means from the moment data is created, during processing, storage, archiving and deletion.

It sounds obvious, but it's anything but. Many companies face invisible risks: missing source data, unclear version control or unauthorised access to sensitive information. Small mistakes, human habits or weak systems can have major consequences over time.

Why is data integrity so important?

The bar is set high in many sectors. Inspection bodies such as the FDA, EMA, WHO or FAGG conduct regular audits, in which data integrity is a regular feature. Gaps in data policy can lead to warnings, production downtime or worse – unsafe products on the market.

Data integrity is therefore a fundamental cog in preventing such situations.

Without reliable data, it is impossible for a company to guarantee that processes are under control and products are safe and compliant.

Yet the benefits of a good policy go beyond compliance alone:

• Safety and quality: You guarantee that end products are effective and safe.

• Efficiency: Correct, well-structured data makes your processes faster and more transparent.

• Lean working: Less time wasted on troubleshooting, adjustments or manual corrections.

• Faster audits: An effective data policy makes it easier to show that your organisation is in control.

In an era of AI, automation and Industry 4.0, this will only become more important. Because how can you rely on AI-driven decisions if you aren't sure about the quality and integrity of your underlying data?

Consequences of poor data integrity: tangible risks for businesses

Poor data integrity has far-reaching consequences for businesses. Recent studies show that poor data integrity can lead to a loss of trust, financial losses and legal risks. An Accenture survey found that 60% of companies facing data integrity issues experience significant financial losses within six months. This not only involves direct costs, but also reputational damage and lower customer satisfaction.

In addition, IBM reported in another survey that companies lose an average of 12 million euro due to poor data quality, mainly due to inefficiencies, data loss and compliance risks.

"The consequences of poor data integrity are not always immediately visible, but the long-term impact can threaten a company's survival." – IBM Report on Data Quality and Integrity (2024)

The evolution from paper to AI: a rapidly changing landscape

Ten years ago, companies were generally moving from paper to digital systems and electronic signatures. Five years ago, it was all about interfaces, automation and connected devices. Today, we have arrived at the AI revolution.

New tools make decisions, generate analyses and even drive production based on data. But in many cases, organisations forget one crucial basic rule: source data must be preserved and untouched. In practice, datasets are edited, combined, copied and so on without it being clear where the original data has gone.

Legislation is lagging behind. Technology is evolving at lightning speed. But that's exactly why now is the time to get your company's fundamentals in order.

Data integrity: the impact in every sector

The importance of data integrity doesn't just apply to one specific sector – it's a universal topic. Whether you're in pharma, biotech, manufacturing, engineering or any other industry, the impact of unreliable data is felt everywhere.

Well-managed data integrity ensures that no matter what sector you work in, you can always count on safe, high-quality products. It ensures that your processes run smoothly, your audits are flawless and you are always compliant with regulations. But more importantly, it paves the way for trust, customer satisfaction and continuous improvement of your product and service offering.

Having all of this under control will ultimately result in significant time savings in managing your systems and processes. Data integrity makes it possible to react faster to changes, proactively identify risks and manage them effectively over the long term, with the end goal being to deliver a safe and high-quality product, no matter the sector you operate in.

What this means in practice

In practice, we see a wide range of questions. Some companies want to rapidly meet the expectations set by inspection authorities after a poor audit, for example. A short, targeted intervention is often enough here. By drawing up a procedure or report, they can once again become compliant.

Other companies engage us for a broader project, such as when multiple audits reveal structural weaknesses in the data policy. In that case, we will develop a roadmap together. We map out all data flows and systems, draw up CAPAs, provide training and supervise the implementation of technical and organisational solutions.

All of this will ensure that these companies have a solid record that allows them to demonstrate that their processes have data integrity – and that they have a clear strategy for the future.

The role of training and awareness

Technology alone is not enough. We put a strong focus on training and awareness at every level of the organisation with each and every customer. From the shop floor to management, it is important that people understand why certain rules apply, and what impact their actions have.

As an example, writing down a password on a post-it note or postponing data entry until two days later are small actions that could have big consequences. Data integrity is only truly anchored when it becomes part of the corporate culture.

Moreover, training isn't just a best practice – it's often also required by law. Data integrity regulations generally stipulate that employees must be adequately trained. However, the legislation often remains vague about how the training should be carried out and what is required, leaving companies with the responsibility for ensuring it is interpreted properly. From our advisory role, we are therefore strongly committed to raising that awareness not just to comply with the rules, but to make truly sustainable improvements.

Are you ready to embrace data integrity?

At Pauwels Consulting, we have the expertise and experience to guide companies step by step to a higher level of data integrity. Whether you want to act quickly after an audit, or take a structural approach to a sustainable strategy: we help you move forward with tailor-made advice, technical support and the right guidance.

Curious about what we can do for your business? Contact us today to find out how we can make your data reliable and compliant now and in the future.