AIR LIQUIDE Medical GmbH (ALM) offers a comprehensive product portfolio of medical and technical gases, equipment and services. With the introduction of a cloud-based integrated SOP management system, ALM relies on the regulatory compliance expertise of DHC Business Solutions.
Medical gases are medicinal products and are therefore subject to GMP guidelines
Oxygen in the medical environment is the most commonly used pharmaceutical product in the world – including in terms of volume – and as such is automatically subject to the highest product safety requirements and European Good Manufacturing Practice (GMP) guidelines. For GMP compliance in the area of computerized systems, Annex 11 of the GMP Guidelines is essential; monitoring authorities are increasingly focusing on this aspect in their regular monitoring practice.
Pharmaceuticals in times of digitalization require next-generation GMP processes
Under pharmaceutical law, there are special requirements for the quality management systems of pharmaceutical companies. It is these requirements and the increasing complexity of regulations due to digitization that have provided the impetus for a fundamental realignment of the quality management system at ALM. In a first step, the management of documents or Standard Operating Procedures (SOPs) and the GMP-compliant digitization of controlled documents were taken into consideration.
“The attention given to the issue has increased significantly in management. This is reflected in a sharpened focus on regulatory GMP requirements according to Annex 11. This changed situation has led us to replace the existing legacy systems with a modern solution”, according to Dr. Carsten Pilger, responsible for Pharmaceutical Support/Regulatory Affairs at ALM.
More regulatory complexity also entails higher regulatory compliance costs. But that’s what ALM wanted to avoid. “Following our digital transformation, we now consistently rely on largely automated, digital SOP processes. Where SOPs were previously created, reviewed, approved and managed in a time-consuming manner – in some cases manually and paper-based – we are now achieving significant technical, professional and process-related advancements.”, says Dr. Pilger.
With DHC VISION for Digital Change of the QM Landscape
GMP compliance is essential for ALM. This requires IT systems that are validated in accordance with Annex 11; and it requires SOP management that is reliable and tamper-proof. Dr. Anne Sieben, Head of QM/QS: “We are in a fundamental change process: We are increasingly organizing our QM landscape with the involvement of all responsible process owners. We hope that this will result in significantly shorter turnaround times for GMP/GDP-relevant documents, less manual use of resources, and greater process efficiency.”.
ALM’s decision in favor of DHC VISION was preceded by an extensive selection process. Dr. Carsten Pilger comments: “We were won over by the high and simple integration capability of the DHC VISION Cloud solution with the Air Liquide IT group standards and specifications. The operating scenario of DHC Business Solutions, with the German Cloud from Microsoft as a basis, creates additional trust in terms of data sovereignty, information security and data protection”.
EU Annex 11 and GMP compliance – simple and smart
As a software system relevant to GMP, DHC VISION must be validated before it is used and then operated in the validated state. In the case of ALM, the validation was carried out with the help of the “DHC VISION Validation Accelerators”. These are templates and process models for all essential steps of validation – from the validation plan to the Part 11 analysis, the user requirements specification (URS) and the test case definition to the final validation report. Such templates are at the heart of DHC’s process- and risk-based validation methodology; it has become widely accepted in the chemical and pharmaceutical industries as it supports a significantly accelerated validation process with substantially reduced effort. Dr. Anne Sieben: “What won us over was DHC’s long-standing and broad validation expertise, as well as the consistently positive recommendations from other companies in the life science industry that already use DHC VISION.”. The solution is operated via DHC’s “Hosting and Application Management Services for GxP-regulated Industries”.
Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions, is looking forward to the long-term collaboration with ALM to implement the digitization strategy. “ALM relies on the cloud-based services of DHC Business Solutions. In the regulated environment, this is not a normal occurrence, but it demonstrates that digital transformation requires pragmatic implementation paths with measurable results in sight. This is precisely one of the key strengths of DHC. “
The Air Liquide Group in Germany, headquartered in Düsseldorf, produces and supplies technical and medical gases and offers related services as well as innovative solutions and technologies for more than 50 different industries. In Germany, 15 million people are supplied with medical oxygen every year. AIR LIQUIDE Medical supplies 900 of the nearly 2,000 hospitals with medical gases and is a reliable and flexible partner for physicians in private practice. In addition to the classic oxygen for inhalation and ventilation, we offer compressed air for breathing, nitrous oxide, xenon, carbon dioxide and pulmonary function gases – all in medical quality. For more information about ALM, please visit: www.airliquide-healthcare.de.