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In the domestic pharmaceutical industry, product approval has been revoked due to regulatory violations and public trust has been shaken, raising questions about improving productivity and strengthening reliability in quality control during the manufacturing process. Accordingly, organic connection between knowledge specialized in the pharmaceutical industry and the system is becoming more important when building a system.

The Ministry of Food and Drug Safety enacted the 'Rules on Safety of Pharmaceuticals, etc. (Prime Minister's Ordinance)' last year to introduce and utilize international manufacturing and quality control (GMP) standards to supply better quality medicines to the public.
The 'Rules on Safety of Pharmaceuticals, etc. (Ordinance of the Prime Minister)' contains the following contents. The introduction of the ‘Pharmaceutical Quality System’ for life cycle management promotes continuous improvement from drug development to production and sales end, including pharmaceutical manufacturing and quality control standards and quality risk management.

With the announcement of the Ministry of Food and Drug Safety, drug manufacturing factories are moving quickly in line with the strengthened regulations.

Due to the nature of the industry, the healthcare sector, which is based on manufacturing, faces two challenges: strict compliance with regulations and quality improvement. In order to solve this problem, it is urgent to minimize the factors of human intervention by workers. This is because artificial factors intervening in the production process and quality control process can lead to quality deterioration and regulation violation. In other words, in order to solve fundamental problems and increase productivity, factory automation using production IT solutions is essential.

In accordance with the need for factory system automation, the domestic pharmaceutical industry is planning to upgrade ERP, centered on large pharmaceutical and bio companies, and is reviewing the introduction of production and quality automation systems (MES, LIMS, EDMS, QMS, etc.).

However, it is a reality that it is being built without considering its own IT design or system linkage, as it reviews global solutions that have entered the domestic market based on overseas references. In particular, it is pointed out that improvement is necessary because foreign products are built without verifying interoperability between systems or each product is introduced without a plan, so there are frequent cases where it is not properly utilized afterwards.

idsTrust, an IT solution specialist, is currently strengthening its healthcare total solution business to improve system construction-related problems in the pharmaceutical industry. In particular, it focuses on optimizing ERP knowledge, production management, and quality control solutions specialized in the healthcare sector, such as pharmaceuticals, bio, food, and cosmetics.

idsTrust develops and supplies pure self-developed solutions (LIMS, EDMS, QMS) for quality management. idsTrust is also building a paperless system that ensures interoperability between systems for GMP documentation, electronic test records and CAPA management in the plant.

In addition, it provides an organic connection with the 'ERP (Enterprise Resource Planning System)', an integrated management point, to increase work efficiency and prepare a rapid decision-making support system. The ERP (SAP) solution is an intelligent solution that provides real-time prediction/risk management, responsibility management, and MBO management status for the entire process from warehousing of raw materials to production and sales to executives, heads of divisions, and general employees. idsTrust specializes in the healthcare industry with ERP to respond to the era of the 4th industrial revolution.

In order to improve the problems of manufacturing and production-related system construction in the pharmaceutical industry, it is important to consider interoperability between systems, understand domain knowledge specific to the pharmaceutical industry, and understand organic linkages between systems. In particular, in the company-wide ERP advancement work, the guarantee of organic linkage between the domain knowledge specialized in the pharmaceutical industry and the existing system is emphasized.

Park Young-ho, CEO of idsTrust, said, “As it is directly related to human health, it is important to establish an automated system to comply with manufacturing process regulations and improve quality in the heavily regulated healthcare field.” He also said, “It is necessary to consider companies that have an understanding of interoperability between systems, domain knowledge, and organic linkages between systems.” Meanwhile, idsTrust plans to expand pharmaceutical and bio-related ERP construction and production know-how and quality control solutions to all areas of healthcare.

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#LIMS #EDMS #LMS #QMS #POP

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