Proofreading
Value becomes visible where nothing happens.
Often overlooked. Indispensable.
Proofreading is one of those activities that often goes unnoticed. When it is done well, it is rarely talked about. Yet it is one of the final and most important controls before a product reaches the market.
We do not see proofreading as a formal comparison of documents. We verify that regulatory requirements have been implemented correctly, completely and consistently in the packaging. In doing so, we look not only at individual text elements, but at the entire information chain, from the source documentation to the finished pack.
For us, proofreading is therefore more than just a review step. It is an essential contribution to the quality and safety of medicinal products.
Proofreading
We always verify regulatory content against the underlying regulatory documentation. We use the Text Verification Tool (Schlafender Hase) to compare content systematically and traceably. In addition, we perform a visual review to ensure that all relevant information is presented completely and correctly.
This combination brings together the strengths of software-assisted verification and the attention of experienced proofreaders. Not every discrepancy can be identified through text comparison alone. Visual changes, layout shifts, or presentation that may lead to misunderstandings despite identical text still require the trained human eye.
Mock-up-Proofreading
Many artwork changes affect only individual elements. A sentence on the folding carton is revised, a section in the package leaflet is added, or the Marketing Authorisation Holder on a foil is changed. The intended change is usually clearly defined.
However, the risk often lies not in the change itself. Any adjustment can unintentionally cause further changes. A logo may shift, a line break may change, or an element may move to a different position even though it should not have been affected by the change.
That is why we do not only verify the intended change. We also check whether anything else has changed. Because when an artwork is changed, only what was actually intended to change should change.
Mock-up proofreading ensures that a specific change does not result in unintended changes to the artwork as a whole.
Beyond Comparison: Taking Responsibility
For us, proofreading is one of the most important contributions to patient safety. Not because differences need to be found, but because they need to be understood.
Automated comparisons, digital tools and AI can support this process. They help make changes visible and identify discrepancies more quickly. However, the real work only begins after that.
Every discrepancy requires expert assessment. Is it intentional or unintended? Is it correct or critical? Does it have an impact on patients, users, manufacturers or supply chains? It is precisely this assessment that determines whether an artwork can be approved or not.
For us, proofreading is therefore neither a search task nor a mechanical comparison of documents. It means taking responsibility for the expert assessment of changes and their potential impact.
Finding differences is easy. Understanding what they mean is where the real expertise lies.
Proofreading in the Age of AI
Software has supported proofreaders for many years by making differences between documents visible. The next major step in this development will not be better detection of discrepancies. The next step will be the assessment of those discrepancies.
We are convinced that, in the future, AI will not only recognize that something has changed, but will also be able to assess what that change means. Is the discrepancy critical? Is it intentional? Does it create a risk for patients or users? This is where the real value begins.
However, for AI to make these decisions, it must first learn from the people who are responsible for making these assessments today. The foundation of any intelligent assessment is the expertise of experienced professionals.
The future of proofreading does not lie in automated comparison. It lies in the intelligent assessment of changes..