The innovative approach supported by cME, starts with:

(1) identifying specific activities that are being performed by QA techs (i.e., Batch record review, audit, clearance and general activities) than

(2) associate an expected duration for each of the define activities. Once the activity is performed,

(3) the QA techs record the information leveraging tablet PC / desktop and

(4) compare the actual duration to its standard. With the information available in cME the project team is now able to

(5) measure the QA efficiency and cycle time and provide the needed visibility to its management. Developing trends, inefficiency root causes by various events / incidents are being recorded and reported on a regular basis.

cME General Flow

§         At the beginning of the shift, QA Techs log in and review pending activities / batch records assignments,  enter expected in-direct activities (i.e., meeting, training) Then, the techs perform & record activities using Tablet PC (i.e., Audits, Inspections, Swabs etc.) or their desktop computer for Batch Record review. While performing their assigned activities, they record observations / action items related to the above.

§         At the end of the shift, each tech updates completions, pass-down notes and provides loss of efficiency reasons and receive an efficiency score.

§         Managers review current activity status, efficiency results and compliance trends via the cME dashboard and initiate Operations Excellence/Lean/Sigma initiatives accordingly.