MedTech Journey Checklist: Establishing a New QMS

Curriculum

• Getting Started with the Checklist
• Implementation Plan
• Determine scope and personnel involved
• Prepare for implementation
• Write Implementation Plan
• Establish timeline for implementation
• Review phases and edit if necessary
• Plan your users, roles, and groups
• Determine document titling scheme
• Plan your attributes/values, tags, and views
• Establish approval matrix for Phase 0 documents
• Establish approval matrix for different document types
• Validate Greenlight Guru (Implementation Phase 0)
• Access Validation documentation provided by GG
• Execute IQ
• Review Validation Report
• Upload IQ and Validation Report
• Determine responsibility for future updates
• Upload and publish Implementation Phase 0 documents to GG
• Users, Groups, and Attributes
• Invite Users into GG
• Add Roles to users
• Create Groups and assign users to Groups
• Phase 1 Documents
• Create Attributes and Values for Document Management
• Create views for SOPs, WIs, Forms, Policies, and GG Validation documents
• Review SOPs, WIs, and Forms from Boost templates and edit as necessary
• Establish first draft of quality manual
• Establish quality objectives and KPIs
• Create Change Order in GG for approving Phase 1 documents
• Complete upload of documents
• Training on Documents
• Create your training matrix using FRM-21-02 from Phase 1 documents
• Upload and publish the training matrix
• Determine Training Needs
• Create Training Events in GG for Phase 1 documents according to training matrix
• Complete training events once all users have completed training
• Training in the Academy
• Create training events for each GG Academy course (if applicable)
• Send users the link to GG Academy and the access code for them to sign up
• Assign users the appropriate onboarding courses in GG Academy
• Create a cover-page document with the GG course title
• Upload and publish the cover-page document
• Create a training event
• Activate training event
• Approve trainee submissions and complete training event
• Optional Professional Course
• Summary
• Summary