Innova ADMT successfully implemented at a Bio-Analaytical Lab of major US Pharma company to review data.

Problem Statement:

• Large amount of samples
• Increasing need for shorter turnaround time without compromising the quality
• Various different quality factors (precision, integration, peak shape , IS performance(RT and variation), carryover, sample abnormalities) to be reviewed with sound scientific assessment.
• Assay performance vary from validation to sample analysis, or from study to study - we need to capture and monitor this.
• Data review process and acceptance criteria at different labs could vary - intensive monitoring is necessary.

• Adapt Innova-ADMT tool to capture data from Bio-Analytical Lab
• Use Innova- ADMT extraction tool to read data out of Analyst software database on a batch basis
• Use Innova-ADMT to “Transform” and “Load” data on a batch basis.
• Use the built in features of Innova ADMT to organize –review- analyze the data acorss programs, Study and Batches.