Why DX is needed in the pharmaceutical industry

  • The environment surrounding drug manufacturing in the pharmaceutical industry is undergoing major changes.
    In recent years, the pharmaceutical industry has been facing increasingly strict regulations in order to correct the rapid increase in products produced in developing countries and the growing number of deficiencies in quality systems caused by the globalization of pharmaceutical manufacturing plants. GMP (Good Manufacturing Practice: standards for the manufacturing and quality control of pharmaceuticals and quasi-drugs) and other strict standards have been established.

    To meet strict standards, data integrity, a GMP requirement, must be addressed.
    This is because in the pharmaceutical industry, protecting the safety of patients, who are the users of medicines, is a top priority, and if there were any inconsistencies, missing items, or even falsification in pharmaceutical records, the health and even lives of patients could be put at risk.
    Companies must strive to ensure data integrity throughout the entire process, from research and development to manufacturing and sales.

    Another major feature is that systems related to pharmaceutical manufacturing are required to undergo validation, which involves "verifying" and "documenting" that the equipment, procedures, and processes required for pharmaceutical manufacturing and quality control achieve the expected results.

Pharmaceutical manufacturing digital transformation solutions

IDEC Factory Solutions provides system construction such as MES (Manufacturing Execution System), SCADA (Supervisory Control System), etc. that meet GMP requirements and data integrity for the pharmaceutical industry, as well as CSV (Computerized System Validation) compliance support solutions.

Overall picture of the solutions we provide

  • Provided solutionMES system construction

    The role of MES is to collect and analyze production line data in real time, identify bottlenecks and waste in the production process, and make improvements. Opcenter Execution Pharma is a representative MES product from SIEMENS, our system integration partner.
    "Opcenter Execution Pharma" is an all-in-one MES package that complies with GMP and covers the entire range of manufacturing operations, from formulation to packaging and shipping.
    IDEC Factory Solutions uses "Opcenter Execution Pharma" to support customers in building MES systems.

    Learn more about MES
  • Provided solutionSCADA system construction

    The role of SCADA is to monitor and control the data sent from various devices and sensors, while accumulating and analyzing the data.
    The SCADA product from SIEMENS, for which we are a system integration partner, is "SIMATIC SCADA SYSTEM (SIMATIC WinCC Audit)."
    IDEC Factory Solutions utilizes SIEMENS' "SIMATIC SCADA SYSTEM (SIMATIC WinCC Audit)" product to support customers in "visualizing production data."

    Learn more about SCADA

Provided solutionCSV(Computerized System Validation)Conformity Support

In pharmaceutical manufacturing, GMP stipulates manufacturing equipment standards to prevent accidental errors and contamination. Validation is the process of verifying and recording whether the manufacturing equipment standards stipulated in GMP are functioning as intended, and according to the Ministry of Health, Labor and Welfare's GMP, validation is defined as "verifying that the structure and equipment of the manufacturing facility, as well as procedures, processes, and other manufacturing and quality control methods, give the expected results, and documenting this."
In addition, for pharmaceutical companies aiming for global expansion, computer validation has become an essential requirement, taking into consideration compliance with US FDA 21CFR Part 11, which stipulates electronic records and electronic signatures.
IDEC Factory Solutions supports computer validation from creating URS (User Requirement Specification) to system testing and operational testing using the model established by the GAMP forum, which is attended by international pharmaceutical engineers.