About Us

Committed to speeding innovation for science-driven organizations, from product ideation through commercialization.

Events

Visit us at the 14th Annual Biological Production Forum

March 2-4, 2015
Dusseldorf, Germany

Hear Us Present

Dr. Justin Neway, Vice President and General Manager - Operations Intelligence, BIOVIA will be presenting 'Achieving the Business and Compliance Benefits of Quality by Design (QbD) and Continued Process Verification (CPV)'.

When: Tuesday, 3 Marc h@ 10.20 - 10.55
Track: R&D Workshop

Abstract
Process and Quality data stored in systems like Paper Records, LIMS, LES, EBR, ELN, Historians, ERP, etc., is organised differently in each system to serve the needs of specialised users who focus on different portions of pharmaceutical production processes.  This creates problems for Quality and Process users who need to perform process monitoring, data analysis and reporting on the process as a whole, to understand the sources of variability through initiatives like Quality by Design (QbD).  It also presents needless barriers to identifying Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s) for implementation of automated process monitoring with alerts for review-by-exception as part of Continued Process Verification (CPV) initiatives.  These users need an automated way to access, aggregate and contextualise all types of process-related data in a validated environment for analysis and reporting without resorting to labor intensive, error prone spreadsheet methods.  This includes all types of process and quality data, including on-line data from real time (PAT) instruments. 

This presentation will describe how pharmaceutical companies have overcome these problems by using a Process Production Operations solution that provides a validated environment for self-service, on-demand access and automated contextualisation of data located in disparate source systems without requiring any alterations to those change-controlled sources systems.

Conference Website >>>

We look forward to seeing you in Dusseldorf!

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