The business challenge:

 

CAPA management is a crucial process in an effective quality management system. CAPA can be a standalone quality process or an outcome of other processes such as customer complaints, deviations, safety incidents, audit observations, change requests and action items, environmental incidents and more.

Metronome was hired by this healthcare company to perform a critical change request, canceling the existing CAPA family records and creating a new solution for CAPA management.

The challenge was to create a new solution that can serve all business units, answering diverse business requirements and handling large family record types.

The company had already implemented Sparta’s QMS TrackWise® Software in selected areas of its business, and had requested to continue and use that QMS.

 

The process:

 

The following project milestones were performed in order to achieve our goals:

 

• Workshops for requirements gathering and analysis for new CAPA processes

• Offering system design and defining FRS document

• Building TrackWise® Software prototype

• Testing prototype, dry runs and fine tuning

• Lock configuration

• Defining and creating relevant reports

• Validation / UAT activities / Creating SDS document

• End User Training

• Go Live

• Post Go Live Support 

 

The successful results:

 

Metromone’s experienced TrackWise® Software QMS Project Manager proved to be of great value to the client’s project team in:

  

• Establishing new global CAPA processes

  • Keeping the family records flexible for standalone and “child” CAPA records

  • Splitting the entire large CAPA family records into different smaller family structure 

  • The solution was configured to manage all related investigation tasks and actions as well, making sure that root cause analysis is performed and documented before moving to the next step in the process

  • Then the user documents the investigation results, Lead Investigator will analyze the findings, formulate the conclusion and log the root cause of the problem

 

• Also CAPA workflows were configured to address CAPA processes related to CAPA tasks, CAPA reports, CAPA effectiveness checks, field actions and CAPA requests. Implementing industry best practice solutions:

  • Keeping a positive user experience by implementing a user friendly system

  • Minimizing end user activities by using automation were possible

  • Keeping intensive team work and brainstorming during the entire workshops

  • Offering Out-of-the-Box thinking for every business or technical concerns

  • Communicating how other companies in the industry resolved these issues/limitations

  • Supporting all team members and maintaining seamless communication to meet project timelines and achieve the desired results

 

 

Customer testimonial:

Quality Application Manager, Global Quality & Regulatory Compliance Department:"We have been very satisfied with the project management and tasks that Metronome's TrackWise project manager has performed for us".