PEMS Application

PharmTech helped a pharmaceutical and biologics manufacturer define the business processes around one of its chemical manufacturing facilities.  Processes defined included CAPA, Maintenance, Equipment Inventory, Cleaning Validation, Lock Out/Tag Out, Management of Change, and Engineering Reporting.  Once the processes were defined, electronic applications were developed and put in place to help manage the processes.  The applications were an integrated suite that provided data integral to the process and prevented the duplication of data. 
 

Metrics

1. Standardized daily processes.
2. Improved productivity.  In one application, a single person was able to perform the environmental reporting that previously took four people to complete. 
3. Provided one true source of data, instead of multiple, silo'd instances of data.