The life science industry has been evolving to a more efficient and competitive industry leveraging Lean and Six Sigma as the main umbrellas to host a range of various operation excellence and cost reduction initiatives. However, while there was a major focus on manufacturing and packaging and more recently the laboratories, the QA has been for the most part left behind.

For many years QA was predominately a compliance organization, its existence was associated with the cost of doing business. While Manufacturing, Packaging, and QC information usually is captured in the ERP/LIMS or other home grown systems, QA information is relatively limited. Our Smart-QA platform can help companies to close this gap.

Smart-QA software and its structured approach helps companies to Improve Efficiency, Improve Value-Added Compliance, Improve Visibility, Reduce Cost, Increase Accountability, Increase Ownership in the QA organization. This solution encompasses all the QA activities such as Audits, Inspections, Clearances, Batch Record Release, Swabs and QA Standards Management and for the first time QA does not have to hide behind compliance in order to justify its existence. Smart-QA is easy to implement, simple to use, and provides few Simple Steps to Improve Shift Management. Smart-QA is a fully web-based application that creates a continuous improvement infrastructure for QA organizations.

The Smart-QA - efficiency management application will assist your Lean / Six Sigma teams by enabling the following:

• Identification of opportunities for Lean Six Sigma projects by measuring deviation from standard and trends/differences/variability in actual performance
• Continuous measurement of the impact of ongoing Six Sigma and Lean projects, so benefits can be measured and corrective actions taken.

Smart-QA is affordable, enhances value added compliance, and implementation takes
ONLY 2-3 weeks.

The following are some of Smart-QA key benefits and value add toward operation excellence:

• Smart-QA is a web-based application that creates a continuous improvement platform for QA organizations. It was developed to help pharmaceutical companies improve their QA efficiency, improve visibility, increase value-added compliance, and increase accountability and ownership.
• Smart-QA supports the QA team in improving managerial capabilities and efficiency management in areas such as: Overall Batch Record life cycle, Audit, Clearances, Swabs, Inspection, Time spent on SOP / Deviation / Monitoring and more.
• Smart-QA provides few simple steps to improve shift and efficiency management, pass down, shift reports and has a real time electronic whiteboard.
• Smart-QA provides robust reporting and trending capabilities and reduces reporting time and data collection time.
• Smart-QA provides accurate and factual quantification for all QA activities and provides clear expectations and standards for each of the QA activities to ensure adequate time is being spent where needed.
• Smart-QA assists Lean / Six Sigma teams in identifying opportunities for Lean / Six Sigma projects by measuring deviation from standard and trends / root causes / variability in actual performance. Smart-QA uses as a continuous measurement of the impact of ongoing Lean / Six Sigma projects, so benefits can be measured corrective actions taken.
• Smart-QA is easy to implement (within 2-3 weeks), and simple to use.

Smart-QA comes with a structured approach to manage QA operation that will help you make the right decision related to projects selection, organizational budget, and provide your production partner with the focused information to improve efficiency and compliance.