Large Biologics firm implements POMS MES for Pharmaceutical Manufacturing

A very large biologics firm used an implementation of POMS to take control of their operational activities and significantly reduce manufacturing overhead while improving accuracy of reports and reducing review time. The company found itself faced with data overflow from multiple systems, a need to refine the data so quality decisions could be made in a timely manner and the need for ongoing regulatory compliance. The problem was tackled top down, cross-functionally and with a long-term outlook. As defined, the goals of the project were to:

· Gather all relevant lot status information in one place
· Facilitate review by exception
· Assign tasks to reviewers based on skills and needs
· Archive material that had been finalized.

Once it was clear what the goals were, the implementation strategy was developed with the following key points:

· Tight control of requirements
· Phased approach to implementation
· Scalable solution

The basic design took advantage of corporate standard software and infrastructure to leverage existing investments and knowledge. Any customized modules were reviewed to maximize reusability and reduce the chance that bugs would creep in. This allowed the client to leverage software infrastructure activities such as development and test, validation, training, maintenance and upgrades. Key features of the implementation included Central System Administration, standard event logging, alert management and report archiving.  The key benefits were a reduction in review turnaround time from 12 – 16 weeks to 1 – 2 weeks, maintenance of ongoing regulatory compliance and reduction in head count of unneeded reviewers.