A Global Diagnostics Medical Imaging Solutions Company selected RCM to program manage, validate, and  implement…

Laboratory

OBJECTIVE

A Global Diagnostics Medical Imaging Solutions Company selected RCM to program manage, validate, and  implement the new Laboratory Information Management System (LIMS).

Initial Goals:

  • Assess, manage, validate, and implement a LIMS’ upgrade from 4.X to 10.X.
  • Coordinate the third-party software upgrade to ensure fail-over in the event of a system failure.
  • Assist in developing the permissions and user access Standard Operating Procedures (SOP).

Expanded Goals:

  • Conduct workshops to train the Team on the new Graphical User Interface (GUI), system, and new user requirements.
  • Partition the server to separate R&D’s access from IT’s and Quality’s access.
  • Modify (commenting out) source code that was obsolete and/or no longer a requirement.

SOLUTION

RCM provided a Sr. Program Manager to manage the program financials (budgets, invoice tracking, and reporting), develop the master validation plan, conduct weekly meetings, and provide status reports to Stakeholder. Team members included Quality, R&D, IT, vendor software developers, vendor project manager, and third-party service providers for IT and Networks.

  • The risk assessment performed at the planning stage was critical in mitigating risks pre- and post-system deployment.
  • Challenges with adoption of the new GUI were successfully addressed during the training.

BENEFITS

  • RCM efforts allowed the Client to implement a modern solution that was easy to use, enabled advanced capabilities, and provided a state-of-the-art system (i.e., hardware and software).
  • RCM met the aggressive project compliance, quality, and delivery goals, on time, on budget and of high quality. RCM Program Manager received a recognition award from Client for outstanding services.

Key Project Elements

Risk Management & Remediation Action

System Validation Execution

Program and Project Management

IT, Regulatory, and Quality Control

Improved Security, Stability, and Safety