Utilizing CORRESSA for Technology Transfer Operations
～ A Foundation of Reliable Communication and Document Management to Achieve Transfer Goals ～
Tech Transfer
Technology transfer projects for pharmaceutical Contract Manufacturing/Development Organizations (CMO/CDMO) are far more than a simple movement of information. They are a critical process that integrates people and documentation across diverse factors—including quality, regulatory compliance, technical specifications, and contractual obligations—to ultimately and accurately reproduce the required product quality.
CORRESSA powerfully drives the Digital Transformation (DX) of these projects by integrating the “precise communication” and “strict documentation management” essential for complex technology transfer success.
Critical Challenges in Technology Transfer Projects
The ultimate goal of Technology Transfer is to ensure that the medicinal product, which replicates the quality of the transfer source, can be manufactured according to plan at the receiving manufacturing site. In the process of achieving this objective, involving multiple organizations, departments, and cultures, several critical challenges arise:
Key Challenges
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Discrepancies in understanding, failure to transfer “Tacit Knowledge,” and inadequate coordination due to differences in language, culture, and corporate climate. |
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Scale-up issues, disparities in facilities/equipment/raw materials, and insufficient understanding of the process. |
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Difficulty integrating inconsistent document structures (numbering, approval workflows) across corporations and sites. |
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Difficulty in ensuring traceability and centralized management of diverse media such as paper documents, scanned data, CAD drawings, and emails. |
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Ensuring adherence to GxP requirements for Data Integrity, anti-tampering, and secure, chronological storage. |
The Solution Provided by CORRESSA
CORRESSA is a collaborative ICT platform designed to overcome these challenges and lead technology transfer projects to success. By moving away from manual, process-dependent operations and implementing comprehensive digital management with CORRESSA, we actively and holistically support the critical aspects of the transfer.
Solution Concept
| Project Management | Resolves planning gaps and visualizes the entire project structure, tracking progress in real-time across all stakeholders. |
| Communication Platform | Centralizes formal business correspondence (Correspondence) between companies to ensure efficient, recorded, and ambiguity-free information sharing. |
| Enhanced Document Control | Provides a common document structure that transcends site and department boundaries, offering a strict document management environment compliant with the ALCOA+ principles. |
Key Features and Advantages of CORRESSA
1) Reliable Inter-Company Correspondence (Correspondence Management)
Formal communication between companies within a project is distinguished from general email/chat and is safely collected and stored within CORRESSA as an official project document.
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All project communication is logged as an official, auditable document, ensuring accurate and secure retention. |
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Supports correspondence that requires internal or external workflow approval before issuance. |
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Accumulated, structured communication becomes corporate knowledge that can be accessed and utilized for future projects. |
2) Strict GxP-Compliant Document Control (Document Handling)
CORRESSA manages the entire lifecycle— ”creation,” “management,” “issuance (distribution),” and “review”—of project deliverables (documents), ensuring compliance with regulations.
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Establishes a management system that adheres to all ALCOA+ principles (Attributable, Legible, Accurate, etc.) required for GxP documents. |
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Handles diverse media (drawings, photos, scanned handwritten records, etc.) and stores them electronically with PDF conversion and an electronic timestamp. |
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Securely retains electronic signatures and detailed approval history, fully ensuring Data Integrity (DI). |
3) Project Progress Visualization and Continuity Support
By utilizing the Document Kanban and Action Kanban (To-Do Management), the progress of documents and task assignments can be monitored in real-time across all involved parties.
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Visualizes the trend of document issuance and final approval, allowing for the early detection of potential delay risks and schedule adherence. |
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Supports the continuity of lifecycle management that extends beyond project completion, including organizational changes, personnel rotation, and ongoing change management, ensuring long-term consistency. |
