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In a pharmacy or a life sciences organization, quality also depends on the people who implement procedures, operating instructions, and controls on a daily basis. A Quality Management System (QMS) may have up-to-date SOPs, complete records, and formally defined responsibilities. However, if staff do not understand the procedures or are unable to apply them correctly, […]

Generative artificial intelligence is rapidly making its way into the operations of pharmacies, pharmaceutical companies, and healthcare organizations: information retrieval, training, translations, draft preparation, preliminary analyses, and administrative support. The potential is real, especially in quality management systems (QMS), where many activities depend on structured documentation, continuous updates, and the ability to quickly retrieve information.

Pharmacies, pharmaceutical companies, and other organizations in the healthcare and life sciences sectors are increasingly reliant on IT systems, cloud applications, email, document management platforms, third-party providers, and digital infrastructure. This evolution increases efficiency and the ability to manage complex processes, but it also creates new operational dependencies. A compromised account, a neglected update, or

Introduction In the pharmaceutical and life sciences sectors, an effective CAPA links five elements: nonconformity, risk, cause, actions, and evidence of effectiveness. If any one of these elements is weak, the process risks becoming nothing more than a collection of administrative tasks: updating an SOP, retraining staff, sending a reminder to the supplier, and closing

For many pharmacies, medical, pharmaceutical, and nutraceutical companies, the first half of the year is often marked by new initiatives, organizational changes, the introduction of new products, updates to documentation, and new operational challenges. In day-to-day operations, attention is naturally focused on operational and commercial activities. However, precisely for this reason, certain aspects related to

In the life sciences sector, acquisitions, mergers, investments and international expansion processes require much more in-depth evaluations than in other industries.In the pharmaceutical, biotech, medical devices and healthcare world, in fact, the value of a company does not depend solely on economic or commercial data, but also on the strength of its regulatory system and

Parallel importation of medicines is an issue of great interest to pharmaceutical stakeholders, particularly importers, distributors, and pharmacies operating in an increasingly competitive and regulated environment. In Switzerland, this practice is permitted but subject to strict requirements set by Swissmedic and the federal regulatory framework. Understanding what is actually allowed and what the critical issues

In the Swiss regulatory environment for medical devices and regulated products, the position of Technical Responsible (RT) is central to ensuring compliance with Swissmedic requirements and the safety of products placed on the market. The term Responsible Person is sometimes used as an international reference, but in the Swiss context the correct designation is Responsible

Medical device traceability is now one of the central elements of regulatory compliance in Switzerland. With the entry into force of the new Swiss regulations aligned with the European framework, the Unique Device Identification (UDI) system has become a mandatory tool to ensure unique identification, patient safety and post-marketing surveillance. For manufacturing companies, manufacturers and

In the life sciences sector, quality does not end with the production of the drug. Distribution also plays a crucial role in ensuring that products reach the end patient in a safe, effective and regulatory compliant condition. It is in this context that GDP – Good Distribution Practice, a set of basic requirements for the