Multinational Pharmaceutical Company

Data automation solution reduced regulatory documentation workload and delivering annual savings through strategic process redesign

Challenge

• Multiple Production Facilities: Data is distributed across different systems in various manufacturing locations, creating complexity in data consolidation
• Regulatory teams currently spend extensive time manually gathering, cleaning, and transforming data from disparate sources
• Numerous documents require detailed quality data in tabulated formats, demanding repetitive administrative work
• Each finished good requires a separate data compilation and documentation process, slowing down regulatory submissions

Solution

• Developed a Proof of Concept (POC) to collect data from multiple LIMSs into an AWS staging zone
• Data ingestion into Foundry, followed by transformation, user validation, and automated document generation
• Intermediate ontology that would store this data for future use and for sharing with the other departments that would need access

Business Impact

• The total impact of the production solution that would come after the POC was calculated in a few millions per year by reducing the time spent on the manual data preparation and validation task
• Automated generation of necessary reports
• Potential for resource reallocation to more strategic tasks due to time saving