Easy Compliance with FDA's New DRAFT Metrics Guidance
FDA has recently released a DRAFT Guidance…
… which requires submission of the following quality metrics:
HarborView has developed a fully customizable, validatable Quality Metrics application that connects to your existing Manufacturing and Quality data, calculates the required metrics and presents them in a set of fully interactive reports containing a wealth of actionable information.
Note that data can be consolidated by our application from sources as varied as spreadsheets on a network folder, enterprise systems like SAP or Sparta Systems Trackwise or your own SQL Server databases housed on premise or in the cloud.
Here we see 3 months of lot acceptance rate information for the entire supply chain. You can see that we’ve included the revenue associated with each lot. This provides a helpful business context for lot rejection rates.
Richard Love has a passion for simplifying complex systems with state of the art database algorithms that transform data into meaningful metrics for the Pharmaceutical and Biological industries. There is a strategic advantage to have meaningful, accurate, and high quality data presented by his approach. Often Pharmaceutical and Biological firms are chasing noise in their quality systems. Richards leadership in this specialized area allows the users to present non-conformances, CAPA, and Change Controls with metrics that determine whether you are in control and with high accuracy. His programs are user friendly and highly automated
Director Quality Control
We can drill down and see the metrics for a single manufacturing site, in this case Sao Paulo by simply checking the box next to its name
We can also see an entire year’s worth of metrics at the Sao Paulo site by clicking the checkboxes next to the months