Increase in focus on Operational Excellence did not skip QA and similar expectations that were set for manufacturing, packaging and most recently QC are now required from QA.

While the focus on compliance remains key for any organization, the need to meet goals such as improved batch record turnaround time, efficiency and transparency in the QA has become key. The understanding of the compliance side of a quality event and the CAPA process remains a major effort yet the need to understand the time and cost involved in allocating QA resources becomes more interesting and essential in order to better understand the overall cost of quality.

Smart-QA provides a configurable integration with systems such as TrackWise to allow the tracking of the activities and actions by QA required to facilitate the resolution and effort associated with a quality event. While in QMS such as TrackWise the company focuses on the work flow, Smart-QA is focused on the operational side of the effort to improve transparency to the time spent and the right first time and turnaround time associated with these events by QA organization.

Furthermore, the integration of Smart-QA with its similar product in the QC operation (Smart-QC) provides the additional visibility to the samples that are being tested and released in the QC to ensure QA team is focusing on release of batch records that have either all the information Available (I.e., samples) and then review and release them vs focus on batch records that the samples associated with them are still 5-10 days away and delaying shipment by focusing on the wrong batch records.

The following outlines the various goals and benefits as well as value added capabilities Smart-QA delivers to a typical organization:

  • QA Executives and Managers can use the Executive Dashboard which outlines Quality operation performance. Key Performance Indicators (KPI) and includes Compliance, Batch Record, Efficiency, and Pass-down.
  • Managers will be able to track and manage any QA Action items derived from any audits, clearances, general activities or manually entered with observation types and details, owners and due dates.
  • QA Managers will easily manage workload and assign tasks to team members at the click of a button through Smart-QA which is a single web based platform instead of multiple disconnected applications. QA Tech and Managers can use this information to manage, assign, re-assign tasks to better distribute and balance the workload for the QA team.
  • QA Managers will be able to manage and measure efficiency for various activities such as Batch Records, Audits, Clearances, Inspections, Swabs, General Activities, and identify Non-Value Added activities for improvement.
  • Your team will be able to reduce batch record release cycle time and help lead documentation errors reduction through improved visibility through Smart-QA. QA Techs will execute batch record reviews for multiple stages, record errors, track cycle time with easy access to status, history, past errors and monitor number of revisions to release the batch.
  • Users can easily view the frequency of events and error rates for various activities and compare them to compliance standards and department procedures. Also, observations/action item types from activities and error types from batch record reviews are tracked and trended by area, type, time period, and owner so systematic improvements can be initiated.
  • QA Techs can use the Smart-QA’s whiteboard to effectively map out their day. User’s whiteboard allows them to see their assigned tasks, add and execute new tasks, observations, action items, and provides feedback on planned, actual, and real time workload and efficiency.
  • Your team will be able to utilize the Pass-down module which provides a collaboration page for different shifts for comments / highlights, overall completed tasks during a given shift by all QA members, any pending activities or action items.
  • Users can define desired search criteria for reporting and can glance at data by selecting a date range and topic (i.e., compliance, efficiency, batch record, choose from over 30 built-in templates designed for presentations. You will be able to reduce time spent on reports/metrics/KPI.
  • With Smart-QA, cycle time for each task and batch record review is tracked and analyzed from the task creation to task execution and wrap up which also helps reduce response time to issues. Current in process activities are also provided for team collaboration.
  • And finally, Smart-QA comes with a structured approach to manage QA operation that will help you make the right decisions related to projects selection, organization budget, and provide your production partner with the focused information to improve efficiency and compliance.