アガサ Company Overview

We are currently sharing a case study on the introduction of Agatha at Kitano Hospital, a public interest incorporated foundation, Tanuki Kofukai Medical Research Institute. At this hospital, while promoting clinical trials with an in-house team and four SMOs, Agatha's facility document storage and IRB were introduced to improve work efficiency and environmental conservation with limited manpower. This has facilitated smoother sharing of IRB documents and improved the work efficiency of the SMO administrative staff, leading to an increase in the number of new clinical trial contracts. To see how the introduction of Agatha has changed the on-site operations, please refer to the specific details in the case study.

We have published the fifth installment of our partner, CAC Corporation's contributed column series, "Points Customers Often Overlook and Unexpected Challenges." The fifth installment focuses on the theme "Key Points and Efficiency in Document Management - Transforming Documents into Assets that Withstand Audits." In CSV (Computer System Validation), one cannot avoid the enormous task of document creation and management. Validation plans, User Requirement Specifications (URS), various specifications, PQ-related documents, reports... Is the act of "creating" becoming the objective itself? This column explains practical points for transforming CSV documents from mere deliverables into "assets" that support audit responses and are useful for future change management. ■ Key Points - Efficiency through the use of Word templates and styles - Design of version control and document numbering rules - Mechanisms to prevent delays in review/approval workflows - Management of finalized documents and assurance of authenticity - Concepts of document management that meet ER/ES and ALCOA+ requirements ■ Column Agenda 1. Breaking free from complicated document creation 2. Designing review and approval workflows 3. Key points for managing finalized documents and asset conversion 4. Utilizing document management systems that comply with GxP requirements

We have published the fourth installment of our partner company CAC's contributed column series titled "Points Customers Often Overlook and Unexpected Challenges." The fourth installment focuses on "Performance Qualification (PQ)." ■ Key Points - Considerations for PQ test planning tailored to business scenarios - Key aspects of validation including data integrity and ER/ES requirements - Realism of test data and differentiation between positive and negative testing - Principles for maintaining test records that can withstand audits - How to assess and manage deviations that occur during PQ ■ Column Agenda 1. Test planning and evaluation policy in PQ: What and how to test? 2. Importance of test data: Creating realistic scenarios 3. Creating and maintaining accurate test records: Principles for audit-ready documentation 4. Pitfalls of deviation management: Responding to unexpected results 5. Summary