With the advancement of global medical technology and the growing demand for healthcare solutions, new drug development has become a key focus area in the biopharmaceutical industry. However, the process of developing new drugs is long, complex, and subject to numerous challenges, including compliance with FDA (U.S. Food and Drug Administration) regulations. In this context, Oracle Agile PLM (Product Lifecycle Management) serves as a comprehensive solution, providing pharmaceutical companies with a regulatory-compliant system management platform to expedite product launches and enhance overall efficiency.

Here’s a case study illustrating how a client chose to establish FDA-compliant new drug development processes on Oracle Agile PLM to address the current challenge of data retrieval across systems, reducing unnecessary gaps during submissions.

Case Study: Client C Establishing an FDA-Compliant Document Management Platform on Oracle Agile PLM to Improve Timely and Accurate Regulatory Submissions

Providing a Centralized Information Platform:

The new drug development process involves a significant volume of data and documents, including experimental data, clinical trial records, manufacturing processes, and more. These data originate from different departments and stages of research and development, scattered across various systems. Effectively managing and integrating these data is one of the primary challenges for pharmaceutical companies in the new drug development process.

Oracle Agile PLM offers a centralized information platform, enabling companies to manage all data and documents related to new drug development in a unified manner. Through this platform, teams from different departments can access and edit relevant data simultaneously, promoting real-time sharing and collaboration. This not only reduces the time spent searching for data but also enhances work efficiency while ensuring data accuracy and completeness, facilitating the smooth progression of new drug development.

Compliance with Electronic Record Standards:

The FDA imposes stringent requirements for electronic records generated during the new drug development process to ensure data integrity and traceability. This includes compliance with 21 CFR Part 11 regulations, which provide explicit requirements for managing and preserving electronic records.

As a system compliant with 21 CFR Part 11, Oracle Agile PLM helps pharmaceutical companies establish an electronic record platform that aligns with FDA regulations. This means that all data and documents generated and stored in Agile PLM meet the FDA’s electronic record standards, guaranteeing a high level of authenticity and reliability. This not only assists companies in smoothly passing FDA reviews but also safeguards intellectual property and trade secrets, ensuring long-term business development.

Assisting New Drug Submissions:

For pharmaceutical companies, successfully passing FDA review and obtaining approvals are critical steps in the new drug development process. However, the new drug submission process is often intricate, involving a plethora of documents and submission data. Improper management can lead to submission delays and unnecessary errors.

Oracle Agile PLM provides a robust collaborative platform and custom kits developed by Anselm, making it possible to swiftly compile documents in compliance with the Electronic Common Technical Document (eCTD) structure, enhancing the efficiency of new drug submissions. With the assistance of Oracle Agile PLM, pharmaceutical companies can more easily submit FDA-compliant submission data, expedite the review process, accelerate new drug launches, and enhance overall efficiency.

Enhancing Regulatory Compliance in the R&D Process:

Compliance with FDA regulations is a crucial aspect of the new drug development process. Non-compliance can lead to delays in product development and result in severe legal risks. The introduction of Oracle Agile PLM helps companies ensure regulatory compliance throughout the research and development process.
First, Oracle Agile PLM provides a comprehensive management system to ensure that data and documents throughout the research and development process comply with FDA requirements. Additionally, Oracle Agile PLM offers a robust review mechanism, ensuring that all relevant documents undergo appropriate review and approval, thereby guaranteeing compliance throughout the product development process.

Secondly, Oracle Agile PLM also provides powerful traceability features, accurately recording all changes and modifications made during the research and development process. This is particularly important during the FDA review process.

In summary, Oracle Agile PLM plays a vital role as a comprehensive solution in the new drug development process. It provides a centralized information platform, enabling companies to unify the management of all data and documents related to new drug development while meeting FDA electronic record standards. Furthermore, Oracle Agile PLM assists with each stage of the application and document submission process, expediting new drug launches and improving overall efficiency while ensuring compliance throughout the research and development process.