Sunday, February 7, 2016

Introducing Drug Stability Data Management and Advanced Statistical Engine in ProcessPad


Stability Data Capture: Formulations of Intermediate, Drug Substance, and Final Drug Product

Testing for stability and trending for shelf life prediction is an important activity of engineers and scientists involved in pharmaceutical or biologics drug development and manufacturing. With the addition of a stability module within ProcessPadTM platform, scientists can now perform this important aspect of process data management and analysis without the need of exiting (or exporting the data) to an external system. Within ProcessPad’s existing process sample test data management capability, we have extended the capability of the software to capture and trend drug stability data. We have made minimal changes to our existing test/assay data capture format to ensure no additional training for lab and QA personnel entering, verifying, and approving data.

The stability management console supports specification limits management for each marketing region and tracks both quantitative and qualitative specifications. Users can flag protocol events/addendums or method changes for better correlation of data and quick compilation of protocol data, events, or addendums throughout the entire life-cycle of the protocol execution.

Shelf-life Prediction: ProcessPadTM advanced statistical engine

ProcessPadTM platform now comes embedded with an advanced statistics engine for predicting shelf-life for long term storage condition. All the shelf-life prediction models designed for poolability of batches conforms to statistical approaches mentioned in ICH-Q1E (Appendix B2.2). 
 


Founded in 2010, Simplyfeye Softwares Private Ltd. provides data analytic products and solutions to life science processing companies. Its ProcessPadTM software enables these organizations to maximize the value of their quality metric, process, QC and manufacturing data throughout the product lifecycle. Simplyfeye is partnered with The WindshireGroup, LLC for marketing and servicing ProcessPadTM in the Americas.

ProcessPadTM uses a browser interface to provide easy on-demand access, across functions and with suppliers, to data for aggregation, management, visualization, and analysis. Organizations benefit from more efficient use of human resources; process improvements and higher manufacturing yields; more robust investigations and troubleshooting; higher product quality; and better regulatory compliance.

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