In the biopharmaceutical production world we are always surrounded by all kinds of quality impacting non-conformances. Typically a site triage team investigate these non-conformances that involves folks from Production, QA and QC (and sometimes people from Process Development or Manufacturing Sciences) to meet periodically to track, resolve, assign root cause and identify corrective and preventative actions. This cross-functional team needs information from variety of cross-functional data sources quickly to resolve issues. Typical information sources that are scraped during an investigation are shown in image below as the basic building blocks of an investigation process. Instant access to the data from these building blocks (in the context of the non-conformance) is very essential so that the group can resolve these on the fly while having discussion during the meeting itself.
Most often in investigations assay background data like system suitability, calibration curve details (that help in assessment of assay fitness) are difficult to access and may get overlooked from the information platter due to hastiness in getting to an assignable cause and CAPA. If the assay background data is available instantly the team can readily answer questions related to
• sources of variability in assay results
• re-evaluate assay suitability criteria and variability in system suitability itself
• variability in calibration curves and assessment of its limits criteria
• variability in internal reference standards
• and much more….
ProcessPad(TM) now has the capability of bringing the test results’ background assay data along with other investigation building blocks on the same single access window. This will help triage team get instant access to all relevant data and readily get answers to their investigation related queries right there during the triage meeting. A typical trend outcome (via ProcessPad) for an assay system suitability is shown below
About ProcessPad(TM)
ProcessPad(TM) is bio+pharma process management software to manage process data in development and commercial manufacturing of biopharmaceuticals.
© Simplyfeye Softwares Pvt Ltd, Hyderabad, India | info@simplyfeye.com | http://www.simplyfeye.com
No comments:
Post a Comment