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Articles on Compliance, Validation & Risk

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Articles on Compliance, Validation & Risk

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The NIS-2 Regulation, which will come into force in fall 2024, will for the first time also require small and medium-sized pharmaceutical and medical technology companies to demonstrate effective meas...

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The NIS-2 Regulation, which will come into force in fall 2024, will for the first time also require small and medium-sized pharmaceutical and medical technology companies to demonstrate effective measures to protect their digital infrastructure. In order to implement the corresponding requirements o...

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For a long time, the V-model was considered the standard procedure for software development projects in GxP-regulated environments such as the pharmaceutical or medical device industry. With the increasing spread of agile development methods, however, the question also arises here of how the advanta...

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IT projects usually focus on two essential factors: first of all, successful, and usually also newly designed, processes that define how end-users should use IT systems. The next step is the systemic implementation of these processes in the software application. The second factor for implementing IT...

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Pharmaceutical companies need particularly responsive and professional emergency and crisis management because they bear a special responsibility in supplying the population with drugs, some of which are vital. With customized and effective Business Continuity Management (BCM), they should therefore...

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Manufacturers of medical technology are legally obliged to monitor multiple obligations and tasks at their suppliers at all times. Many companies are not aware that they are also liable for unsuitable suppliers. Our risk-based approach to supplier management ensures security, enabling companies to v...

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Quality awareness in the regulated industries, above all in pharmaceuticals and medical technology, manifests itself in a large number of "good practices", where the letter replacing "x" in the formula "GxP" denotes the field of application. Three areas are particularly relevant here: firstly, GMP f...

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Whether transporting hazardous materials or planning a normal route: supply chains harbour both risks and opportunities when it comes to aligning the company with sustainability goals. Four levels of action are decisive in taking advantage of these opportunities in supply chain management and at the...

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In many companies, handwritten signatures verify that everything is conducted according to regulations in essential work steps. This, for example, is how employees vouch for the creation and release of work and process instructions. The procedure is also widely accepted for the release of test speci...

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Even in the highly regulated environment of the pharmaceutical and medtech industry, a legally compliant and fully digital archiving of documents is possible. "Substitute scanning" provides the necessary basis.

Paper or digital format? As soon as it comes to documents that have to be retained, most c...

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How fast can the best suited drug against a viral infection be developed: in years, months or weeks? That depends on the application – and to which extend new technologies such as AI (artificial intelligence) are used in the development process? A prime example was provided by an AI algorithm from t...

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Supplier qualification is an integral part of any pharmaceutical quality management system (“QMS”). Outsourced activities need to be managed and controlled – see EU GMP Guide Part 1 Ch. 1.4. (vii) and ICH Q10. Furthermore, in addition to the actual definition and control of outsourced activities, Ch...

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Best practice: Using process mining and RPA in a regulated environment

A key metric from the Regulatory Affairs department illustrates the enormous effort involved when coordinating between pharmaceutical companies and regulatory bodies: Approximately every fifteen minutes, the Regulatory Affairs dep...

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Artificial Intelligence (AI) and Augmented Reality (AR) are key technology trends that are conquering and changing industrial sectors in an evolutionary and disruptive manner. Both in health care as well as within the pharmaceutical and medical technology sectors, this opens up opportunities to reth...

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Partner or risk? This question is not at all trivial, especially for the pharmaceutical industry with its global production. Although digitalization measures can ensure greater transparency in quality management, the fact that drug recalls and bottlenecks are still fairly common only goes to show th...

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There are dozens of ways to interpret the term “Artificial Intelligence” (AI) – not just in literature or movies, where we encounter AI as the red camera eye HAL 9000 or in the shape of a humanoid robot. In pharma industry and medical engineering, however, the term AI can be narrowed down to machine...

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Today, even language assistants like Alexa and Siri are becoming the target of data privacy topics. The associated challenges are something many companies are already very familiar with. For some time they have been working to ensure maximum transparency about where and which data they store – and w...

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