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 innovation
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.

Framework program
Eureka
Call title and identifier
Eurostars 2025
Submission and evaluation scheme
Anticipated project budget
Coordinator required
No
Deadline for EoI
12/03/2025
Deadline of the call
12/03/2025