CASE STUDY
Situation_ VSAM Knowledge Solutions provided a Prgm/PM/Business Analysis resource that led projects and programs for a client at 3 sites in particular there was a Data Integrity gap assessment and remediation project that identified 60 equipment to be assessed for gaps and mitigated for risks.
Obstacle__ The scope was to provide a data integrity gap assessment, remediation/mitigation of risks plan for the identified 60 pieces of equipment and implement the changes for compliance or mitigate risks to data integrity within a $575K budget.
Actions __The resource led 3 PM contractors to conduct a 3 phase approach. The 1st phase was a preliminary assessment of equipment that had risks to Data Integrity. The 2nd phase was to identify the data integrity gaps and the compliance to category under 21 CFR Part 11 and Part 210 and 211 regulations. The 3rd phase was to establish a remediation plan with timelines that update of SOPs and/or validation documentation that included Validation Plans (VPs), User Requirement Specifications (URS), Functional Specifications (FS), Hardware/Software Design Specifications (DS), Traceability Matrix (TM), Installation Qualification (IQ), Unit Testing or Operational Qualification (OQ), System Integration Testing (SIT), and User Acceptance Testing (UAT) or Performance Qualification (PQ), Configuration Records, Reports, Deviations and User Process Monitoring (UPM). Regular project status updates were provided through Clarity software to the IT PMO and project sponsor updates. IT PMO deliverables were provided through gate reviews (Project Charter, Project kick-off, Risk Workshop, WBS, Capacity Planning, Risk Log and Project change requests). Updates were provided to finance obtaining data from Oracle and vendor forecasts and to assist in carryover as well as Capex budgeting.
Results_ Gap Analysis documentation was established and SOPs were updated and all 60 pieces of equipment were successfully mitigated for data integrity risk on time and on budget.
