Software plays a critical role in medical technology, as its reliability and safety can directly affect the health and lives of patients. To ensure that medical software fulfils the high requirements, thorough software validation is essential. But what exactly does validation mean in this context and why is it so important? What are the different aspects of software validation in medical technology and how can the findings be applied to ERP software validation, such as SAP Business One?
Read MoreAI for SAP Business One puts the user at the centre
The business software of the future will be fundamentally changed by artificial intelligence (AI). Instead of struggling through complex menus, users will be able to interact with the software in natural language. This development opens up many new opportunities and benefits for companies, especially for SMEs. We can already see how AI makes SAP Business One easier to use with the industry solution for medical technology.
Read MoreMDR-compliant ERP solutions for medical technology
Medical technology is facing numerous challenges due to strict regulations and rising costs. The MDR (Medical Device Regulation), in particular, presents companies with considerable challenges. Although transitional periods until the end of 2028 can be utilised, medium-sized medical technology companies in particular must take action.
Read MoreManage SAP Business One access rights
The administration of SAP Business One access rights plays a central role. This can quickly become a challenging aspect of SAP B1 management,
Read MoreNo GoBD without process documentation
Today, all companies must comply with the GoBD-compliant storage of certain documents. However, correct archiving alone is not enough. The specific measures and procedures to be taken must be set out in procedural documentation.
Read MoreManage batches for medical devices
Companies that manufacture medical devices in particular are obliged to manage these products in batches. This applies in particular to all products for implantation, in-vitro diagnostics and all products manufactured from substances of animal origin. Batch management for medical devices is a legal requirement that must be strictly adhered to. The batch number documents both the manufacturing process and the raw materials used. Under certain circumstances, batch numbers can be used to initiate product recalls.
Read MoreGMP standards for ERP in the pharmaceutical industry
Good manufacturing practice (GMP) is a system designed to ensure that products are consistently manufactured and controlled according to quality standards. It was developed to minimise the risks associated with any pharmaceutical production that cannot be avoided by testing the product.
Read MoreHigh data quality through ERP systems
Many companies still do not know how to maintain high data quality. Wrong figures or disgruntled customers can quickly shake up an already weakening company.
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