Summary
- Profile Type
- Research & Development Request
- POD Reference
- RDRTR20241223004
- Term of Validity
- 23 December 2024 - 23 December 2025
- Company's Country
- Turkey
- Type of partnership
- Research and development cooperation agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- Turkish SME is seeking a partner to co-develop innovative software that transforms Excel usage in the pharmaceutical industry. This solution addresses the challenges of data integrity, regulatory compliance, and efficiency in Excel-based data management. By providing features like 21 CFR Part 11 compliance, automated validation, and advanced data security, the software empowers pharmaceutical companies to enhance data quality, reduce risks, and improve overall operational efficiency.
- Full Description
-
The company's Innovative Software Solution for Compliant Excel Usage in Pharma.
The company is at the forefront of revolutionizing data management in the pharmaceutical industry. This software addresses the critical challenges associated with Excel-based data management, particularly the complexities of ensuring compliance with stringent regulations like 21 CFR Part 11.
Addressing the Challenges: Pharmaceutical companies face numerous challenges when managing Excel-based data, including:
- Validation complexities: Ensuring that Excel-based systems meet the rigorous validation requirements outlined in 21 CFR Part 211.68(b) is a time-consuming and complex process.
- Documentation burden: Maintaining detailed documentation for each Excel file and its validation process can be overwhelming.
- Version control: Tracking changes and ensuring data integrity across multiple versions of Excel files is difficult.
- Security risks: Protecting sensitive data from unauthorized access and ensuring data integrity is paramount.
Proposed Solution: The software provides a comprehensive solution to these challenges. The platform offers:
- Automated validation: Streamlined validation processes aligned with 21 CFR Part 11 requirements.
- Centralized repository: A secure and centralized location for storing and managing all Excel-based data.
- Version control: Robust version control mechanisms to track changes and ensure data integrity.
- Audit trail: Detailed records of all user activities and system changes.
- Electronic signatures: Secure and compliant electronic signatures for data approval and authorization.
- Customizable workflows: Tailored to meet the specific needs of different pharmaceutical organizations.
- Integration capabilities: Seamless integration with existing enterprise systems.
Key Benefits:
- Enhanced compliance: Ensure full compliance with 21 CFR Part 11 and other relevant regulations.
- Improved data integrity: Protect data from errors, loss, and unauthorized access.
- Increased efficiency: Streamline validation processes and reduce manual effort.
- Reduced risk: Mitigate the risks associated with non-compliant Excel usage.
- Better decision-making: Provide accurate and timely data for informed decision-making.
By partnering with Turkish SME, pharmaceutical companies can gain a competitive advantage and ensure that their data management practices are robust, compliant, and efficient. - Advantages and Innovations
-
Innovative Features and Benefits:
This software offers several innovative features that set it apart from other solutions:
- Automated validation engine: Advanced algorithms automate the validation process, reducing the risk of human error and ensuring compliance with 21 CFR Part 11.
- Intelligent document management: Proposed system automatically generates and manages all required documentation, including validation plans, protocols, and reports.
- Role-based access control: Granular control over user permissions ensures that only authorized personnel can access and modify data.
- Real-time monitoring: Continuous monitoring of system performance and data integrity to detect and address issues promptly.
- Scalability: Easily adapt to growing data volumes and organizational needs.
Key Advantages:
- Reduced validation time: Accelerate time-to-market for new products.
- Improved data quality: Ensure the accuracy and reliability of data.
- Enhanced regulatory compliance: Mitigate the risk of regulatory findings and penalties.
- Increased efficiency: Streamline processes and reduce operational costs.
- Future-proof: Our software is designed to adapt to evolving regulatory requirements and industry standards.
By leveraging our innovative software, pharmaceutical companies can:
- Enhance data integrity and compliance: Ensure that all data is accurate, reliable, and compliant with regulatory requirements.
- Improve operational efficiency: Streamline processes and reduce costs.
- Mitigate risks: Reduce the risk of data breaches, regulatory findings, and product recalls.
- Gain a competitive advantage: Differentiate themselves from competitors and strengthen their brand reputation. - Technical Specification or Expertise Sought
-
For our EUREKA grant program, Turkish SME is looking for partners with expertise in the following areas:
- Software development,
- Database design and management,
- Cloud technologies,
- Data security and compliance (e.g. 21 CFR Part 11),
- User interface design,
- Pharmaceutical industry regulations. - Stage of Development
- Under development
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR status
- IPR applied but not yet granted
Partner Sought
- Expected Role of a Partner
-
The ideal partner for this project will play a pivotal role in the development and implementation of this innovative software solution. The company anticipates that the partner will:
- Contribute to the technical development: The partner will be responsible for the design, development, and testing of the software, ensuring it meets all functional and performance requirements. Provide expertise in regulatory compliance: Given the stringent regulatory requirements of the pharmaceutical industry, the partner should have a deep understanding of 21 CFR Part 11 and other relevant regulations.
- Leverage their industry knowledge: The partner should have experience working with pharmaceutical companies and understand the unique challenges faced by the industry.
- Contribute to the project team: The partner will collaborate closely with project team throughout the project lifecycle, providing technical expertise and guidance.
- Share resources: The partner will provide the necessary resources, including personnel, infrastructure, and funding, to support the project.
- Mitigate risks: The partner will work with us to identify and mitigate potential risks associated with the project. In essence, Turkish SME seeks a partner who can:
- Complement our team: Bring complementary skills and expertise to the project.
- Share our vision: Be committed to the success of the project and align with our goals.
- Contribute to innovation: Help us develop a truly innovative solution that meets the needs of the pharmaceutical industry. - Type and Size of Partner
- University
- SME 50 - 249
- R&D Institution
- SME 11-49
- Big company
- SME <=10
- Type of partnership
- Research and development cooperation agreement
Call details
- Framework program
- Eureka
- Call title and identifier
-
Eurostars 2025
- Coordinator required
-
No
- Deadline for EoI
- Deadline of the call
- Eureka
Dissemination
- Technology keywords
- 01003006 - Computer Software
- Market keywords
- 02007012 - Medical/health software
- Targeted countries
- All countries