We visualize the systematization of our customers' business processes and provide step-by-step support for system design, development, and implementation from the customer's perspective.
**Overview of System Implementation Support Services for Pharmaceuticals and Medical Products** ● Current Situation Survey / Hearing / Proposal Investigation of the current situation, analysis, and issue extraction Hearing customer requirements Verification of compliance validity Preparation of RFP, product selection, supplier selection, audits ● Requirement Definition / Basic Design / Compliance Validity Preparation of requirement definition documents Preparation of basic design documents considering functionality, operation, and scalability Verification of compliance validity regarding requirements and system functions ● Detailed Design / Coding / Unit and Integration Testing (Manufacturing) Creation of detailed design documents based on the basic design documents Coding according to the detailed design documents Conducting unit and integration tests for each function, evaluating results, and making improvements Conducting QC and preparing essential documents according to quality management standards ● Comprehensive Testing / Environment Setup / Data Migration Preparation of a test plan (including IQ and OQ elements) followed by comprehensive testing If there is migration data, conducting migration tests in advance and migrating the data Conducting QC and preparing essential documents according to quality management standards ● Training / Support / Operation and Maintenance Conducting training (for users/administrators) according to the education program and maintaining training records Maintenance services (subject to consultation)
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basic information
The personnel assigned by our company will vary depending on the scope of the target business and the scale of the system. Please feel free to contact us first.
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Applications/Examples of results
We have supported over 20 companies in computerized system validation in pharmaceutical companies, medical institutions, and other research organizations. We can also provide partial support for the system development process. We will provide resources and support tailored to your situation. Additionally, we will assist with system operation management after the system goes live (details below): - Inquiries regarding operations - Monitoring of operational status - Change management - Incident management (cause investigation, improvement proposals, permanent solutions, and recurrence prevention)
Company information
Our company is committed to promoting appropriate IT investments and utilization in businesses by investigating the current situation, including operations, environment, and strategy, and proposing and providing systems that align with the original business, scale, and regulations while suppressing excessive investment in IT. In particular, we focus on the development, sales, and support of software related to the entire process of research and development of pharmaceuticals for the pharmaceutical industry, as well as supporting pharmaceutical development operations and providing consulting for IT implementation, all while offering comprehensive support for systems that comply with the regulations (ministerial ordinances and guidelines) of the Ministry of Health, Labour and Welfare. Please feel free to contact us if you have any inquiries.
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