Manufacturing Data & Operations Audit Service
Bioproduction Group are experts in biopharmaceutical operations. We’ve worked with some of the world’s largest biopharmaceutical manufacturers, analyzing data from literally hundreds of data sources including chromatography skids, DeltaV, PI, SAP and many other historians.
Bio-G’s Manufacturing Data and Operations Audit Service uses our wealth of experience in consolidating multiple data sources and building models that optimize biopharmaceutical manufacturing facilities.
MANAGING COMPLEXITY
Based on our considerable experience in biotechnology manufacturing, Bio-G’s audit service provides an understanding of the effect of complexity on your manufacturing operations.
Our audit service will review and summarize your current data sources and the toolsets you are using today to grapple with complexity, and outline the most important improvements you can make to manage complexity in your manufacturing operations.
COPING WITH AN AVALANCHE OF DATA
Biopharmaceutical manufacturers are overwhelmed with an avalanche of data from automation systems, lots of databases, and other measurement systems in the facility. Our audit service will look at your current range of data sources and then outline key ways this data can be better understood and leveraged using a variety of tools.
We will at the conclusion of our audit, recommend how your data can be turned into real information and then into knowledge that will empower particular groups in manufacturing operations to make better decisions.
DATA GATHERING AND MODELING GAP ANALYSIS
One of the critical needs for a business is to understand how their current data gathering, process modeling, and analysis toolsets meet their needs, and how they can be improved.
Our audit service will perform a gap analysis to determine where your data gathering and modeling frameworks overlap or contradict. We will identify gaps and recommend processes and toolsets to meet those gaps.
Based on our considerable experience in biotechnology manufacturing, Bio-G’s audit service provides an understanding of the effect of complexity on your manufacturing operations.
Our audit service will review and summarize your current data sources and the toolsets you are using today to grapple with complexity, and outline the most important improvements you can make to manage complexity in your manufacturing operations.
AUDIT PROCESS
The audit process begins with analysis of your current data sources, including all current historians, automation systems, batch records, and process documentation. We analyze this data and conduct a tour of your facilities, noting critical bottleneck areas and how your systems and processes operate. We also meet with key engineers in your facility, to understand how your data, toolsets, and models are used.
We will review this information in light of what we’ve seen in our many past projects and what we know to be best practices. The audit process and service concludes with a report outlining the concrete steps we recommend to improve key performance metrics — whether that be process improvements, new toolsets, or some other step/s.
BENEFITS
Our intimate understanding of biotechnology manufacturing processes, combined with our robust products and services have resulted in millions of dollars in annual savings for our clients. Our audit service is our entry-level service, and the recommendations we make at the conclusion of each engagement will lead to immediate improvements at your facility.
Our audit service is also the foundation for our additional services in data gathering and consolidation, and then building models that deliver even more value to our clients.
