System Validation Support Service (for Pharmaceuticals and Drug Development)
System Validation Support Service
We support the implementation of CSV to meet regulatory requirements and demands related to the use of electronic records and electronic signatures.
In the process of research and development of pharmaceuticals and post-marketing, computer systems are utilized in compliance with regulatory requirements at each stage of drug development to ensure consistently high quality through computer system validation. - Requirements Definition and Basic Design Phase Participate in meetings for requirements definition, review the User Requirements Specification (URS) and confirm business and regulatory requirements, and create a Computer System Validation (CSV) plan. Examine basic functions, configuration details, and necessary functions for business and regulation, and create a functional specification document. Conduct a risk assessment to determine the validation level based on risk levels and create a traceability matrix. - Detailed Design and Development Phase Create an Installation Qualification (IQ) plan and a list of verification items, and obtain approval. Review design and functional specification documents, create an Operational Qualification (OQ) plan, and obtain approval. Review business flow and operational design, create a Performance Qualification (PQ) plan, and obtain approval. - Verification and Reporting Phase Support OQ activities as a tester and test leader, create and obtain approval for the OQ report. Support PQ execution, create and obtain approval for the PQ report. Organize validation-related documents and records, and create a comprehensive CSV report based on the results.
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basic information
This service will be provided in accordance with your rules from your perspective. (Basic deliverables) 1. User Requirements Specification (URS) 2. Validation Plan (VP) (Validation during relocation/changes) 3. Functional Specification (FS) Application Functional Specification (FS1) 4. Design Specification (DS) Application Design Specification (DS1) 5. Traceability Matrix (TM) 6. Installation Qualification Plan (Infrastructure) 7. Installation and Operational Qualification Plan (IOQP) (Application) 8. Operating Manual 9. Standard Operating Procedures 10. System Training Plan (TP) 11. Performance Qualification Plan (PQP) 12. Performance Qualification Script (PQS) 13. Performance Qualification Report (PQR) 14. Nonconformance Records, Change Management Records 15. Start-up Approval Document 16. Validation Report (VR) *Partial support is also possible depending on your resource situation. Our response will vary based on the scope of the target operations (GxP) and the scale of the system.
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Delivery Time
Applications/Examples of results
This service has a track record of supporting over 30 companies, including pharmaceutical companies, medical institutions, and other research organizations, regardless of the size of the system.
Detailed information
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1. At the start of the project, we will create a Work Breakdown Structure (WBS) and, after reaching an agreement with the client, we will proceed with the project according to the WBS while monitoring the actual versus planned progress to avoid delays. The WBS will be managed in a shared folder, which our company will update daily to maintain the latest status. 2. Throughout the project, any doubts or issues that arise will be managed using an "Issue Management Table" for each team. Issues will be reviewed in weekly team meetings to ensure that no unresolved issues remain. Issues that cannot be resolved within the team will be escalated to the PM for resolution. 3. At the end of each phase, we will hold a phase transition assessment meeting to determine the transition to the next phase. We will check the impact of any unresolved issues or delayed tasks on the next phase and make a decision regarding the transition. - All tasks in the current phase are completed - Deliverables that need to be created have been confirmed and approved - Any issues that have arisen are resolved or there is a clear outlook for resolution
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Standard Approach to CSV - The basic policy for CSV is implemented as follows based on the GAMP methodology issued by ISPE (International Society for Pharmaceutical Engineering). - The implementation level is determined based on the software category and risk assessment using the GAMP V model, and is defined in the project plan. - CSV is defined as Category 4, which assumes the use of packaged products configured to meet specific business requirements. Additionally, if functionality is added or customized to the product as needed, a separate risk assessment and evaluation of importance and impact will be conducted to identify the verification level and carry out validation (Category 5).
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Basic Model of CSV Activities in GAMP When utilizing functions that depend on the configuration settings of products (Software Category 4), a CSV approach is taken. However, if the customer has validation policies, rules, or procedures, they will be adhered to.
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.