MedTech Journey Checklist: Implementing a Legacy QMS

MedTech Journey Checklist: Implementing a Legacy QMS

Get your QMS up and running so it can start working for you. This section will guide you through implementation of a legacy QMS in GG.

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Curriculum

  • Getting Started with the Checklist
  • Implementation Plan
  • Determine scope and personnel involved
  • Perform Gap Assessment
  • Establish timeline for implementation
  • Upload Legacy QMS Documents
  • Migration of training records
  • Migration of Quality Process records
  • Migration of Project records
  • Legacy system translation sheet
  • 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
  • Create Attributes and Values for Document Management
  • Create views for SOPs, WIs, Forms, Policies, and GG Validation documents
  • Phase 1 Documents
  • Review SOPs, WIs, and Forms from Boost templates and edit as necessary
  • Revise quality manual (if applicable)
  • 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
  • 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 for users who are new to the medical device Industry
  • Summary
  • Summary

Curriculum

  • Getting Started with the Checklist
  • Implementation Plan
  • Determine scope and personnel involved
  • Perform Gap Assessment
  • Establish timeline for implementation
  • Upload Legacy QMS Documents
  • Migration of training records
  • Migration of Quality Process records
  • Migration of Project records
  • Legacy system translation sheet
  • 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
  • Create Attributes and Values for Document Management
  • Create views for SOPs, WIs, Forms, Policies, and GG Validation documents
  • Phase 1 Documents
  • Review SOPs, WIs, and Forms from Boost templates and edit as necessary
  • Revise quality manual (if applicable)
  • 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
  • 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 for users who are new to the medical device Industry
  • Summary
  • Summary

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