JuneBloom

JuneBloom - Core Consultation Offerings: - GxP System Support - System Selection & Implementation - Computer Software Assurance (CSA) - System Security and Access Control - System Administration - Change Management, Release management, Compliance Verification - Build & Connect/Integrate Quality Systems (paper-based & electronic) - Ensure Systems are “right-sized” and “phase-appropriate” - Computerized System Validation (CSV), Administration, & Maintenance - Development/Review of CSV Documentation - Execution of CSV Test Scripts - Quality Assurance Review/Approval of CSV Materials Quality Management System (QMS) Support: - QMS Implementation, Validation, Administration - Process Mapping, Process Improvement - Author/Update Documents (Policies, SOPs, WIs, Job Aids, Forms, Templates) - Vendor/Supplier Management & Oversight Program Development/Support - Internal and External Audit Program Development/Support - QMS Function Support (Deviations, CAPAs, Change Controls, etc.) - Risk Management - Quality Management Review GxP Training Program Support: - Learning Program Development & GxP Compliance - Learning Management System (LMS) Implementation, Validation, Administration - Training Material Creation & Update - GxP Employee Curriculum Vitae (CV) and Job Description (JD) Management - New Hire Onboarding Document & Record Control/Management: - Document Management System (DMS) Implementation, Validation, Administration - Document Migration & Archival - Document Periodic Review and Update