Precision at Scale: Global BioPharma Leader Transforms QMS with 99.9% Data Accuracy

Faced with the need to modernize its quality management infrastructure, a BioPharma leader turned to Sikich QMS Solutions to lead a high-stakes data migration from a legacy on-premise system to a cloud-based platform. The initiative demanded more than just technical execution. It required deep expertise in handling complex data transformations, preserving full audit traceability, and maintaining data integrity across highly regulated environments. With business-specific scenarios and compliance requirements adding layers of complexity, the client needed a partner who could deliver precision and reliability. Sikich rose to the challenge, while laying the foundation for a seamless legacy system decommissioning and future scalability.

Functionality Delivered

Sikich QMS Solutions executed a validated, end-to-end data migration that consolidated records from multiple legacy systems into a unified cloud-based platform. The full-scale data migration project that included: 

• Migrating records from multiple On-Premise legacy systems into a single system requirements digital platform. 
• Applying complex data transformation logic and scripts to align legacy data with system requirements. 
• Working closely with business teams to capture and implement detailed business rules and scenarios. 
• Conducting multiple dry runs to ensure data accuracy and stability. 
• Generating and attaching Audit Trail Reports to each record, preserving historical change logs. 
• Creating Single Record Reports based on custom logic for simplified record review. 
• Executing migration in a validated environment, including the performance of System. 
• Installation Qualifications (SIQs) to meet compliance standards. 

Business Benefits

By achieving 99.9% data accuracy and implementing a validated migration approach, we helped the client meet stringent regulatory and quality standards critical to BioPharma operations. The delivery of comprehensive Audit Trail and Single Record Reports ensured full traceability, supporting both internal reviews and external audits. Automation of complex transformation logic significantly reduced manual effort, while the move to a streamlined, cloud-based QMS improved system performance, scalability, and accessibility. With legacy systems fully decommissioned, the client now benefits from reduced infrastructure costs and a future-ready platform built for growth.

Here are some of the key advantages the client gained:

• Delivery of Audit Trail and Single Record Reports providing end-to-end traceability and support for audits. 
• Data was delivered with 99.9% accuracy, maintaining high integrity and reducing post-migration Issues. 
• A validated approach leveraging SIQs ensuring the migration met regulatory and quality compliance standards. 
• Automation of transformation logic and scripts during the migration process saving significant time and manual effort. 
• A streamlined, cloud-based QMS with improved accessibility, performance, and scalability. 
• A seamless consolidation of all records managed on a single, scalable cloud-based platform. 
• A smooth decommission of legacy systems, significantly reducing licensing and infrastructure maintenance costs. 

Is your BioPharma organization preparing for a digital transformation or facing the complexities of a data migration project? Whether you’re navigating regulatory requirements, consolidating legacy systems, or striving for data integrity at scale, Sikich QMS Solutions brings the precision, validation, and industry expertise needed to ensure success.