The business challenge:

 

Metronome was hired to lead and implement a solution for Risk Management Plan Management System (RMP MS) for global Patient Safety & Pharmacovigilance in all the customer’s business units worldwide.

The solution was intended for managing and tracking Risk Management Plans (RMP’s) and required pharmacovigilance activities and risk minimization activities according to regulations within EU, in order to ensure that the customer fulfilment of obligations to the various Competent Authorities.

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:

 

SOW and Project Plan were created with the customer consent to include a full-scale design and implementation of the required solutions: 

 

• Workshops for requirements gathering and analysis

• Offering system design and defining FRS document

• Building TrackWise® Software prototypes

• Testing prototypes, dry runs and fine tuning

• Lock Configuration

• Definition and creation of reports

• Validation / UAT activities / Creating SDS document

• End User Training

• Go Live

• Post Go-live Support

 

Some of the major project milestones included:

 

• Workshops Analysis Phase – We have performed several workshops with the customer global project team for gathering and analysis of requirements to achieve processes harmonization.

• System Design Phase – In between workshops we offered different system design approaches, including configuring several prototypes in SandBox environment so customer is able to test the offered solutions and reach a well-substantiated decision on the right one, as well as declare on lock configuration.

• Rekeying final prototype to Development – We performed full system structure in Development environment until a complete solution was established.

• Creation of reports – Reviewing customer reports URS documents and designing Crystal Reports templates.

• Testing and Validation – Conducting dry runs and validation / user acceptance testing activities on system configuration and report templates.

• Go Live – We successfully migrated the complete and validated solution into the Production environment, and established login account user roles and membership. 

 

 

The successful results:

 

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

 

• Facilitating the customer’s Risk Management processes

  • One global solution that is in compliance with multiple local/global regulatory authorities

  • Harmonizing the global RMP family records processes

  • Submission process that can be referenced and facilitate multiple submissions to different authorities

  • Easily trackable submission process that also provides submission status report to senior management

  • Keeping the RMP family records simple and flexible

  • Providing enhanced system permissions for business process owners where applicable

 

• Implementing industry best practice solutions

  • Minimizing end user activities by using automation were possible

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

  • Following customer URS but keepingan open discussions during workshops

  • Providing alternatives and workarounds for every business or technical system limitation

  • 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:

 

IT Manager, Clinical R&D Division: "The RMP is live in production. Thanks a lot to Metronome team for all the hard work during the project!"