Data Management for Nitrosamines Project

A German pharmaceutical company approached Zamann requesting support in Data Management for the Nitrosamines/NDSRI Project.

Challenges Faced

Data Management: The Manufacturing company’s data on suppliers, and Drug Products is stored in different formats and locations—spreadsheets, email systems, and isolated databases—without a centralized or standardized system to manage it. Data Management was required as a starting point for the Nitrosamine Project as a central reference for all critical information about the drug product, ensuring consistency, regulatory compliance, and efficient project execution. Without it, data gaps and inconsistencies could lead to delays, quality issues, and regulatory risks.

Zamann Pharma Support’s Approach

Regulatory Compliance: The Master Data system played a crucial role in identifying drug products that need testing. It acts as a centralized repository for all critical information related to drug products, enabling streamlined decision-making, prioritization, and compliance with regulatory requirements.
Improved Documentation: Having centralized and comprehensive Master Data for Drug Products significantly enhanced documentation processes within the organization. All product-related data—such as formulations, testing requirements, manufacturing details, and regulatory approvals—was stored in a single Master Data repository. Automatic retrieval of accurate data reduced manual data entry errors in documents such as Certificates of Analysis (CoA), Batch Records, and Quality Records.
Risk Mitigation: Effective Master Data Handling can significantly reduce risks in various aspects of business operations, Master Data ensures that all product information—such as specifications, manufacturing processes, and batch records—aligns with regulatory standards (e.g., FDA, EMA, ICH).

Results Achieved

Regulatory Compliance: The client achieved full compliance with FDA 21 CFR Part 11, EU Annex 11, and WHO guidelines, significantly reducing the risk of audit findings related to audit trails.
Streamlined Processes: The newly implemented SOPs provided a structured and repeatable process for conducting periodic reviews, ensuring consistency across all systems.
Risk-Based Review Frequency: The risk assessment SOP allowed the client to prioritize critical systems and allocate resources efficiently, focusing on high-risk areas.
Empowered Staff: With comprehensive training and detailed procedures in place, the client’s teams gained the confidence and skills needed to manage the Audit Trail Periodic Review independently.
Enhanced Data Integrity: By identifying and addressing potential anomalies through periodic reviews, the client strengthened their data integrity framework, ensuring the reliability and traceability of their computerized systems.

Client Testimonial

“Despite the initial challenge of having no consolidated information in a single list, Zamann Pharma’s approach to data management was exceptional. They established clear systems for organizing, tracking, and updating critical information, ensuring nothing was overlooked. The use of collaborative tools and meticulous attention to detail allowed us to navigate the complexities of the project with confidence.“

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