Data Integrity (DI) Consulting

Home/ Services/ Consulting/ Data Integrity (DI) Consulting ConsultingData Integrity (DI) Consulting What is Data Integrity? Data integrity refers to the completeness, consistency, and accuracy of data, and it is required to be ensured throughout the lifecycle of pharmaceuticals. To ensure data integrity, the principles of ALCOA+ are presented within various guidelines. Principles of ALCOA+ 1.Attributable: Data can be attributed to who did what, when, and where. 2.Legible: Data can be read by anyone. 3.Contemporaneous: Data is recorded and created at the time it occurs. 4.Original: Data is original or equivalent to the original. 5.Accurate: Data is recorded and created accurately. 6.Complete: All data exists, not just parts of it. 7.Consistent: Data is consistent and without contradictions. 8.Enduring: Data is protected long-term and exists throughout its lifecycle. 9.Available: Data is accessible and available for use at any time.   Ensuring data integrity is required for all data and records, regardless of whether they are on paper or in electronic form. It is an urgent issue in the pharmaceutical industry, as the reliability of data and records is directly linked to the reliability of the quality of the pharmaceuticals. Data Governance The establishment of data governance requires active involvement from senior management. Senior management is responsible for establishing the organization’s quality culture, maintaining and continuously improving it, and building an effective data governance system. They are also responsible for creating a corporate culture that provides an appropriate working environment, where everything can be reported openly and transparently. A quality culture centered around senior management should be established, along with a data governance system that ensures data integrity throughout the lifecycle. Some specific policies and procedures for operating a data governance system include the following examples. (WHO Annex 4. Guideline on Data Integrity) WHO Annex 4. Guideline on Data Integrity ■ management oversight...

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Education/Training Support

Home/ Services/ Education/Training Support ServicesEducation/Training Support We provide education that encourages thinking “why,” not just acquiring knowledge. In the manufacturing and sale of pharmaceuticals and other products, it is essential to comply with various regulations, starting with the Pharmaceutical and Medical Device Act. Moreover, as these products directly affect human and animal lives and health, there is a social mission and responsibility to maintain proper quality while ensuring a stable supply. Therefore, it is required for companies to plan and implement education and training programs for all employees that include mandatory GMP training, compliance, morality, and the ability to think and make judgments. Our education and training support services based on the “GMP Platform,” provide educational content focused on quality (manufacturing). Additionally, we offer education and training support programs that bring together various information and the expertise of our experienced consultants. Through those services, CM Plus assist in solving our clients' issues from the perspectives of both the quality system and the education system. Features of CM Plus Education/Training Support Aggregate of "knowledge", which keeps sharing the latest information On "GMP Platform" (https://www.gmp-platform.com/en/), CM Plus's web service, you can read the latest information and regulations in life science industries, and serial articles. GMP Platform By registering for a free membership, you will be able to access the published information. You can gather information from a series of articles and news topics related to GMDP/QMS. GMP Platform You can learn at any time and as much as you need CM Plus offers eLearning courses which you can use at any time and any place such as open seminars held at a venue or on-site seminars held at our client's office. We offer tailor-made educational programs for companies which are too busy to develop and carry out their own programs. CM Plus's...

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Technical Information Services

Home/ Services/ Technical Information Services ServicesTechnical Information Services The environment surrounding facilities and equipment requiring advanced environmental control, such as those in the life sciences and semiconductor sectors, is evolving to become more international, diverse in scope, and demanding in terms of information processing.Our company, which thrives on challenges in engineering and life sciences manufacturing quality, offers comprehensive information services to support our clients’ international operations. These services address topics related to GMP (Good Manufacturing Practice), QMS (Quality Management Systems), and the latest technological advancements, including digitalization.In addition, we provide product services that include engineering information tools and education and training related to quality. GMP Platform Aggregating knowledge to solve our clients’ challenges GMP Platform is a free information site established based on CM Plus Corporation’s founding principle of addressing various quality-related issues in life sciences facilities while staying close to our customers. We offer a variety of technical articles and translated and explained guidelines. In addition to GMP (Good Manufacturing Practice), we also share information related to clinical and non-clinical studies, as well as quality and safety for medical devices, cosmetics, and even food products. CM Plus aims not only to disseminate the expertise of our experienced in-house consultants and engineers through this site but also to gather and integrate knowledge from top consultants worldwide to help solve any challenges our clients may face. GMP Platform Internet Virtual Exhibition for Life Science Life Science Company Information Platform Life Science Company Information Platform is a specialized portal site where top suppliers, who constitute the robust supply chain in the life sciences industry, showcase and share extensive information on their latest technologies, products, and services. Those seeking the latest information on technologies, products, and services related to life sciences can access a wealth of information from various perspectives provided by the...

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Projects

Home/ Portfolio/ Projects PortfolioProjects Japan Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation Pharmaceuticals and Medical Devices Manufacturing facility for bio-based Class IV implantable medical devices CoreTissue BioEngineering Inc. Cosmetics “Show” cosmetics factory TOYO BEAUTY CO., LTD. Pharmaceuticals and Medical Devices／Packaging Aiming to create a factory that "responds to rapidly changing customer demands and stay ahead of the competition for 15 years" Iwata Label Co., Ltd.(currently IL Pharma Packaging Co., Ltd.) Pharmaceuticals and Medical Devices／Medium-Molecule API Cost reduction through separate sub-contracting Jitsubo CO., LTD. Data Centers System module type data centerRealizing short construction period and low cost Internet Initiative Japan Inc.(IIJ) Other Countries Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility that considers people, the community, safety, and the environment. Terumo Vietnam Co., Ltd. Food／Flavor・Fragrance Smooth project execution between Asia headquarter and Japan head office Takasago International Singapore Pte. Ltd. Pharmaceuticals and Medical Devices Production line reinforcement for pharmaceutical manufacturing factory Medreich Limited The above are examples of our achievements.Please feel free to inquire about our achievements in your field of interest. Related Contents →Performance by Numbers

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Consultants

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