October 10, 2024 - Ahmedabad, India - Octalsoft, a leading provider of Clinical Trial Management Systems (CTMS), is thrilled to announce the launch of its advanced Quality Assurance (QA) module. This innovative module is designed to streamline and enhance quality management processes in clinical trials, offering a range of comprehensive features such as audit plan generation, audit report creation with observations, Corrective and Preventive Actions (CAPA) management, and robust compliance tracking.
Key Features of the Quality Assurance Module:
Audit Plan Generation:
A. Customizable Audit Plans: Allows users to create detailed and tailored audit plans, ensuring all necessary aspects of the trial are covered.
B. Scheduling and Tracking: Facilitates easy scheduling of audits and tracking of their progress, ensuring timely completion.
Audit Report Creation:
A.Observation Logging: Enables detailed documentation of observations during audits, ensuring comprehensive records of findings.
B. CAPA Management: Provides a platform for documenting and tracking Corrective and Preventive Actions, ensuring issues are promptly addressed and resolved.
C. Report and Certificate Generation: Automates the creation of audit reports and compliance certificates, saving time and reducing errors.
21 CFR Part 11 Compliance
A. Regulatory Compliance: Ensures all audit processes and documentation meet the stringent requirements of 21 CFR Part 11, guaranteeing data integrity and security.
B. Electronic Signatures: Supports electronic signatures, enhancing the authenticity and traceability of audit documents.
Auto Email Notification:
A. Timely Alerts: Sends automatic email notifications to relevant stakeholders about upcoming audits, audit findings, CAPA updates, and report availability, ensuring everyone stays informed and responsive.
Observation Matrix:
A. Trend Analysis: Visualizes trends in audit observations, helping to identify recurring issues and areas for improvement.
B. Observation Areas: Categorizes observations by areas such as protocol adherence, data integrity, and site compliance.
C. Internal and External Audits: Differentiates metrics for internal audits conducted by the sponsor and external audits by regulatory authorities, providing a comprehensive view of audit performance.
Benefits of the Quality Assurance Module:
A. Enhanced Quality Management: By providing tools for detailed audit planning, observation logging, and CAPA management, the QA module ensures rigorous quality control throughout the trial process.
B. Regulatory Compliance: Ensures compliance with 21 CFR Part 11, providing peace of mind that all audit activities meet regulatory standards.
C. Increased Efficiency: Automates key processes such as audit scheduling, report generation, and notifications, reducing administrative burden and freeing up time for more critical tasks.
D. Improved Communication: Auto email notifications keep all stakeholders informed about audit activities and findings, enhancing collaboration and response times.
F. Insightful Analytics: The observation matrix offers valuable insights into audit trends and areas of concern, supporting proactive quality management and continuous improvement.
Summary
Octalsoft's new Quality Assurance module represents a significant enhancement to its CTMS platform, providing clinical trial teams with robust tools to ensure quality, compliance, and efficiency. By automating and streamlining key QA processes, this module empowers organizations to maintain the highest standards of quality control, meet regulatory requirements, and drive continuous improvement in clinical trial management.
About Octalsoft
Octalsoft is a leading provider of Clinical Trial Management Systems (CTMS) designed to streamline and optimize the management of clinical trials. With a focus on innovation and customer satisfaction, Octalsoft delivers comprehensive solutions that enhance the efficiency, accuracy, and compliance of clinical research.
Contact Information
Priyanka Singh
Octalsoft
380015
Voice: 07622098622
