CASE STUDY

Computer Software Validation Implementation Goals:

Data Analytics

OBJECTIVE

Computer Software Validation Implementation Goals: develop a project plan that addresses issues, and execute to plan. RCM’s team was required to qualify / validate / move / decommission / calibrate  50+ pieces of equipment.

Meet FDA Regulations | Manage Resources | Track and Resolve Issues | Keep Steering Committee Informed | Deliver Project on Time and Budget

SOLUTION

  • Managed the CSV project from inception to completion.
  • Ensured that the project requirements met FDA regulations.
  • Developed and/or reviewed and signed off on the Validation Documentation: Master Validation Plan (MVP), Risk Assessment, Software Requirements, User Acceptance Testing (UAT) and UAT Training, and Go Live activities.
  • Managed team and budget, reported status to team and Stakeholders, tracked tasks and activities, and resolved issues.

RESULTS

  • Worked with cross-functional business teams and quality teams to define team roles and responsibilities.
  • Coordinated Discovery Sessions for Data Migration from Legacy system to new system.
  • Maintained project repository to ensure all decisions, documents, data spreadsheets were retained.
  • Collaborated with 3rd party vendor to ensure project alignment of goals and objectives
  • Established and followed the change control process when scope increased due to new technical and/or functional requirements
  • Developed Business Readiness activities that needed to be completed prior to Go Live.
  • Identified Operational impact prior to Go Live and developed required SOPs.
  • Developed monthly Project Newsletter and distributed to all users of the system to keep them informed of project progress.
  • Conducted a project post-mortem meetingiatthe end of aproject to determine what went right and what could be improved.

Key Project Elements

Identified team Developed Risk Assessment and Project Plan

Developed MVP Reviewed Documents for US regulations

Assisted with UAT, User Training and SOP development​

Launched system on time, on budget, and of high quality.​