制药业生产系统验证 - EBR/MES 系统验证
System validation in the pharmaceutical industry is a crucial process to ensure that computerized systems are fit for their intended use and meet current regulatory requirements. This is a mandatory requirement of cGMP (current Good Manufacturing Practices) and is essential for managing the quality of manufactured products. Any computerized system that could affect Patient Safety, […]
EMS 是制造业实现卓越 ESG 的催化剂
In today’s world, businesses are increasingly facing pressure to operate in a sustainable and responsible manner. This is not only due to environmental concerns, but also because consumers and investors are increasingly demanding ESG (Environmental, Social, and Governance) performance from the companies they support. Energy Management Systems (EMS) can play a critical role in helping […]
医药产品生产解决方案。在 cGMP 下工作的义务。
The pharmaceutical industry is responsible for the development, production, and distribution of medicines and other healthcare products. In order to ensure the safety and efficacy of these products, pharmaceutical companies must comply with strict regulations, including cGMP (Good Manufacturing Practices). cGMP is a set of regulations that outline the requirements for the manufacturing of pharmaceutical […]
在符合 cGMP 要求的过程中保持数据的完整性
Data integrity is the linchpin of pharmaceutical manufacturing under Current Good Manufacturing Practices (cGMP). It ensures that data generated throughout the manufacturing process is accurate, reliable, and secure. In this comprehensive guide, we explore the critical role of data integrity in cGMP compliance. We’ll begin by providing a detailed explanation of cGMP, followed by the […]
通用主批次记录 (GMBR) 如何提高包装效率
In the pharmaceutical and manufacturing industries, Generic Master Batch Records (GMBRs) are increasingly being used to improve packaging efficiency. GMBRs are a type of master batch record that groups together similar workflows, reducing the number of individual MBRs required. This can lead to significant savings in time and resources, as well as improved compliance and […]
汽车4.0--如何可持续地生产并保持最高质量标准？
Manufacturers operating in the automotive industry are currently facing a major challenge – maintaining competitiveness while mitigating the environmental impact of production processes requires them to use modern, advanced technological solutions. In the era of Industry 4.0, how can sustainable production and high quality standards be maintained? Key challenges in the automotive sector The automotive […]
质量检查（SPC）
一款质量检测软件，可在生产现场进行检测，并在偏差演变为缺陷之前实时发出警报。.
电子批处理记录--制药业的自动化和纸张消除
It’s no secret that every step of the pharmaceutical manufacturing process must be documented. However, managing paper documentation can be extremely time-consuming for pharmaceutical manufacturers, and human error can be relatively common. For this reason, pharmaceutical companies decided to implement what is known as Electronic Batch Record (EBR) in order to both streamline workflow and […]
如何为SPC报告收集数据 - 自动和手动测量？
SPC, or statistical process control, is one of the most interesting tools in the context of quality management. Nowadays, this method is widely used in the industrial sector. During this process, data is gathered for report preparation base on control cards. Meanwhile, by gathering and displaying measurements in real-time, we are able to decrease […]
如何管理生产中的返工？
Let’s be honest – the term “rework” is most commonly associated with delays in production. Technically speaking, rework means correcting failed, defective, non-conforming items. It is essential to reduce manufacturing and production rework and repairs in order to save money and achieve higher quality across the board. However, this requires detailed planning and strategies that […]