Design And Implementation Of LIMS In The Global Pharmaceutical Industry

Pfizer is a leader in the global healthcare market, with manufacturing facilities throughout North America, South America, Europe, and Asia-Pacific. These facilities are responsible for manufacturing Active Pharmaceutical Ingredients, Intermediates, finished pharmaceuticals, nutritional products, over-the-counter medications, biopharmaceuticals and vaccines. Pfizer is responsible for ensuring that all of these products are manufactured in compliance with company Quality standards and with regulations issued and governed by regulatory bodies such as the Food and Drugs Administration(FDA).The key objective for the LIMS program is to continue to provide significant business value in the areas of compliance and productivity across the Pfizer global supply chain network of manufacturing sites, their supporting QC laboratories, QA functions and key 3rd party partners through standard business processes and system utilization. To harmonization the lab analyses, share the supporting strategy and reduce the operation cost across the whole company network.This thesis mainly completed the following contents:1. Build-up the lifecycle process of Sample, test and result management.2. Deign the architecture and the LIMS network infrastructure.3. Design of the non-standard LIMS database structure.4. Design of the lot creation, sample login, sample analysis, test and sample review, Lot disposition and SAP/LIMS interface,user security and used the UML to modeling the functions.5. The implementation and validation of the LIMS application meet the requirements of the Business need.The LIMS system is deployed across the labs in 5 different countries successfully. The LIMS implementation make the lab operation paperless management, share the static information, reduce the cost, improved compliance and consistency, and improved efficiency and productivity.