CheckX Solutions Group provided operational excellence program & project management expertise for a cutting-edge contact lens installation/qualification/validation project. Implemented key project management business solutions including metrics tracking of equipment installation and validation performance and a new project management method (Lean-Agile) to dramatically compress the validation completion timeline while pulling forward the market release schedule for saleable product. Custom Development included in the following:

Calibration Master Record Automation:

The program required criticality assessments and master calibrations records for approximately 4800 equipment devices. The volume of work (24K sheets of paper) to perform these documentation activities in the current manual fashion placed the project schedule at immediate and significant risk of delay. CheckX developed & delivered a semi-automated solution which allowed the team to complete all calibrations prior to the Installation Qualification due dates, thus avoiding downstream schedule impact.

Project Schedule Dashboarding:

Management of over 10,000 tasks across 35 individual project schedules in a coordinated and consistent fashion to always steer the program in the right direction. No usable enterprise application solution available; network inconsistency prevented a master schedule from being utilized. Data analysis, reporting and metrics generation to support this large program was impractical given the technology limitations. The solution CheckX developed was to programmatically extract data from each schedule and consolidate the information in a master data sheet. The data was then utilized to create a pivot table which facilitated the filtering of data. Business logic was integrated into the pivot in order to highlight ‘At Risk’ activities requiring immediate attention.

Plateau Training Dashboarding:

Ensuring training compliance prior to starting key qualification activity milestones is time consuming and inefficient. CheckX developed a training dashboard utility that provides training analytics and a score card view with insight at the user, role, or shift level.

CheckX Solutions Group also researched, designed and created the Project Management Office (PMO) blueprint which enabled the PMO to report and track budget as well as corresponding documents utilizing MS Office Enterprise & Project Window Access. Validated Enterprise Quality Management System (EQMS): TrackWise & Infor LN 10 ERP.

CheckX Solutions Group validated several “off the shelf” solutions. Included all aspects of Computer System Validation general principles and approaches that FDA considers appropriate elements of validation. (URS/SDS/FRS IQ/OQ/PQ) Included Project Management and automated test case development as well as load testing.

Our organization developed & delivered custom ERP functional testing application.

CheckX Solutions Group engaged to model existing Remedy software enhancement update process. Remedy is the mission critical application that CSR’s utilize to enter customer problem tickets. Remedy generates millions of new entries a year. Software bugs were showing up in production causing system downtime which equals money lost. CheckX designed & implemented workflow process which has eliminated bugs entering production environment.

The Healthcare Integrated General Ledger Accounting System (HIGLAS) is a new dual-entry accounting system that replaces and modernizes the existing fee for service Medicare Contractor accounting systems with a single standardized system. Brought in to migrate Medicare contractors from legacy systems. Required extensive testing via QTP/VBS coding. Manual tasks which required 160 hours to complete are now automated, and the process now executes in 32 regularly scheduled off-peak hours saving 128 hours per instance per iteration (Six total instances).