Operational Technology
OT security
Såhär har vi löst tidigare utmaningar Case NIS2 GAP-analys visar vägen framåt för Hermes Medical Solutions Problem Behov av en tydlig nulägesbild och konkreta steg för att säkerställa att de möter NIS2-kraven och att stärka cybersäkerheten. Lösning Djupgående analys av rutiner, system och säkerhetsåtgärder med fokus på internationella standarder, styrkor och förbättringsmöjligheter. Resultat Hermes fick […]
Operations and plant management
Production planning
Såhär har vi löst tidigare utmaningar Case 1 Case 2 Industribolag vässar sin Sales and Operations Planning (S&OP) Problem Ett industribolag behövde effektivisera sin S&OP-process som präglades av manuellt arbete i kalkylblad, bristande överblick och långsam kommunikation mellan funktioner och externa parter. Lösning Med Opcenter APS (Planning-modulen) digitaliserades och centraliserades planeringsarbetet. Visualisering och simulering möjliggjorde […]
Facility information
Såhär har vi löst tidigare utmaningar Case Från splittrad dokumentation till effektivt underhåll Problem Ett reningsverk på Västkusten hade sin anläggningsdokumentation spridd i flera system, med olika versioner av samma dokument. Underhållspersonalen la mycket tid på att hitta och verifiera information. Lösning All dokumentation importerades till COMOS och kopplades till utrustningen. Tekniska data integrerades, och […]
Manufacturing and automation
Traceability and quality
Maintenance
Om tjänsten Datadrivet och prediktivt underhåll som minimerar stillestånd Traditionellt underhåll bygger ofta på reaktiva insatser, manuell planering och dokumentation som bara finns på kontoret. Det leder till stress, onödiga stopp och slöseri med resurser. Vår lösning gör underhållsarbetet datadrivet, synkroniserat och effektivt, oavsett om du jobbar vid skrivbordet eller ute i anläggningen. Genom att […]
Automation
Såhär har vi löst tidigare utmaningar Case 1 Case 2 Case 3 Helautomatisering av OKQ8:s depåhantering i Sundsvall Problem Den egenutvecklade, personberoende depålösningen behövde standardiseras – med bättre spårbarhets- och uppföljningsmöjligheter. Lösning En ’Next Generation Terminal Management System’ i form av en helhetslösning med integrerad mjuk- och hårdvara från Siemens digitala portfölj. Resultat Helautomatisk och […]
Industrial digitalization
Planning & Supply chain
GAMP5
During the training, you will gain insight into the regulatory requirements and how computerized systems should be quality assured in an effective way. You will get an overview of the content of GAMP 5 with a focus from a perspective for you as a requirement setter, customer, supplier and manager of system solutions, for GxP and MDR-regulated activities. Review of international standards such as EU [...]
GAMP5
Computerized systems are an essential part of the pharmaceutical and medical device industry, from research and development to clinical trials, manufacturing and distribution. Computerized systems used in the GxP environment must be reliable and adapted to their needs. This course provides an understanding of regulatory requirements and how to effectively quality assure computerized systems. Content The training day [...]
Medtech software
Software work in Medtech, such as Medical Device Software (MDSW), Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), is a highly regulated field. Developing software in this sector therefore requires extensive knowledge of applicable regulations such as MDR and IVDR, as well as guidelines and standards such as MDCG, IEC and ISO. The understanding [...]
Medtech software
Explore the frontiers of medical software development! During the training you will get an overview of how MDSW, SaMD and SiMD are related and which regulations they are subject to. Theoretical aspects, such as intended purpose, classification and detailed design in software development, are mixed with practical case studies and exercises. We follow a medical device through the entire product development process, and you will have the opportunity to [...]
Software for medical devices
The course begins with an overview of the applicable rules and regulations, starting with the Medical Device Regulation (MDR) with regard to software. We discuss software documentation in a technical file, including verification and validation, and you get an introduction to risk management and usability. In addition, the training covers the system life cycle of a Medical Device Software (MDSW), focusing on [...].
System management
Effective systems management is crucial in regulated industries such as pharmaceuticals, where careful control and oversight of computerized systems is required. These systems, which are critical for everything from research and development to manufacturing and distribution of Pharma, must be managed to ensure consistent performance and compliance with strict regulatory standards. A robust system management helps to [...].
ISO 13485
ISO 13485:2016 is an internationally recognized standard for quality management systems specifically adapted for medical device companies. It is designed to support companies and organizations involved in the design, production, installation and service of medical devices and services. The standard emphasizes the importance of meeting regulatory requirements as well as customer requirements, and is intended to be used by both internal [...]
GMP
All pharmaceutical manufacturers intending to market or manufacture their products in the EU must comply with good manufacturing practice (GMP), regardless of where in the world they are based. GMP defines the minimum standards that a pharmaceutical manufacturer must meet in its production processes. By following GMP, manufacturers can systematically prevent contamination, errors and inconsistencies, which is crucial for patient safety. Compliance [...]
Validation & qualification
Validation and qualification are a fundamental part of the pharmaceutical industry and other sectors of the life sciences industry. These processes ensure that equipment, method, process, premises and systems meet specified requirements and perform reliably for their intended use, meaning that they consistently deliver the expected product and function. Accuracy in these processes is essential [...].