Greenlight Guru | Implementation Services
Scope of Work (SOW)
Please refer to the executed contract for applicable services.
Guru Implementation Services: Document Migration
Deliverables: The current version of the customer’s documents will be uploaded into the customer’s Greenlight Guru QMS environment.
- Previous versions of documents may be brought over en masse for historical reference in a single zipped folder, if requested by the customer.
- Before Document Migration can begin, all users who are document authors and/or owners shall be added, and all groups used for document sharing shall be set up in the customer’s Greenlight Guru environment.
| Step |
Task |
Responsibility |
| 1 |
The customer shall meet with Greenlight Guru to introduce the project and present the required information needed from the customer. |
Customer and Greenlight Guru |
| 2 |
Custom attributes and values shall be determined and added by the customer, with suggestions from Greenlight Guru as needed, to organize and structure documents during migration. |
Customer |
| 3 |
The customer shall fill out a document datasheet, provided by Greenlight Guru, with the necessary information about the documents to be uploaded. |
Customer |
| 4 |
The customer shall provide Greenlight Guru access to their Greenlight Guru production environment, the customer’s documents to be migrated, and the completed document datasheet. |
Customer |
| 5 |
Greenlight Guru shall upload the provided documents into the customer’s Greenlight Guru production environment in accordance with the information outlined in the customer’s completed document datasheet. |
Greenlight Guru |
| 6 |
The customer shall meet with Greenlight Guru for a summary of the completed work. |
Customer and Greenlight Guru |
Timeline: Customer has 120 days to submit the document datasheet. If the data has not been received, the services are considered delivered and are no longer redeemable. Greenlight Guru has 90 days to complete the services after the meeting has been held and Greenlight Guru has received the document datasheet from the customer.
Guru Implementation Services: User Configuration
Deliverables: All Users will be added to the customer’s Greenlight Guru environment, assigned roles, and added to Groups.
- Users will be assigned a User type (Full or Lite) based on functional responsibilities.
- Users will be given appropriate My Company level roles in alignment with their expected permission levels.
- Users will be assigned Groups according to the breakdown defined by the customer.
- Users will each receive one invite from the service. If necessary, reinvites shall be sent from a user on the customer’s internal team with the My Company role of Administrator.
| Step |
Task |
Responsibility |
| 1 |
The customer shall meet with Greenlight Guru to introduce the project and present the required information needed from the customer. |
Customer and Greenlight Guru |
| 2 |
Groups shall be determined by the customer, with suggestions from Greenlight Guru as needed, to organize the users for training and document sharing. |
Customer |
| 3 |
The customer shall fill out a user datasheet, provided by Greenlight Guru, with the necessary information about the users to be set up. |
Customer |
| 4 |
The customer shall provide Greenlight Guru access to their Greenlight Guru production environment, and the completed user datasheet. |
Customer |
| 5 |
Greenlight Guru shall set up the users in the customer’s Greenlight Guru production environment in accordance with the information outlined in the customer’s completed user datasheet. |
Greenlight Guru |
| 6 |
The customer shall meet with Greenlight Guru for a summary of the completed work. |
Customer and Greenlight Guru |
Timeline: Customer has 120 days to meet with Greenlight Guru to introduce the project and present the required user datasheet. If the user datasheet has not been received or the meeting has not been held, the services are considered delivered and are no longer redeemable. Greenlight Guru has 90 days to complete the services after the meeting has been held and Greenlight Guru has received the user datasheet from the customer.
Guru Implementation Services: Training Implementation
Deliverables: Training Requirements will be established in Greenlight Guru to account for all documents and users in the customer’s Training Matrix.
- Before Training Implementation can begin, all documents, users, and groups in the Training Matrix shall be uploaded, invited, and set up in the customer’s Greenlight Guru environment.
| Step |
Task |
Responsibility |
| 1 |
The customer shall provide their existing training matrix to Greenlight Guru. |
Customer |
| 2 |
The customer shall meet with the Guru to plan the translation of the customer’s existing training matrix to the Greenlight Guru Training Management workspace, including Training Requirement titles, descriptions, due dates, methods, trainer, and trainer approvals. |
Customer and Greenlight Guru |
| 3 |
The customer shall provide Greenlight Guru access to their Greenlight Guru production environment. |
Customer |
| 4 |
Greenlight Guru shall input the provided risk assessment into the customer’s Greenlight Guru production environment. |
Greenlight Guru |
| 5 |
The customer shall meet with Greenlight Guru for a summary of the completed work. |
Customer and Greenlight Guru |
Timeline: Customer has 120 days to meet with Greenlight Guru to introduce the project and share the training matrix. If the training matrix has not been received or the meeting has not been held, the services are considered delivered and are no longer redeemable. Greenlight Guru has 90 days to complete the services after the meeting has been held and Greenlight Guru has received the training matrix from the customer.
Guru Implementation Services: Design Control Migration
Deliverables: The current version of the customer’s design control traceability matrix will be added into the customer’s Project workspace.
- All provided User Needs, Design Inputs, Design Outputs, Design Verifications, and Design Validations will be added and linked together.
- Related Items, Jira links, Design Reviews, and Attachments are not included in this service.
| Step |
Task |
Responsibility |
| 1 |
The customer shall provide their existing design control traceability matrix. |
Customer |
| 2 |
The customer shall meet with Greenlight Guru to plan the translation of the design control traceability matrix into the Greenlight Guru Projects workspace, including Component setup, Titles vs Descriptions vs Notes, DC owners, and Tags. |
Customer and Greenlight Guru |
| 3 |
The customer shall provide Greenlight Guru access to their Greenlight Guru production environment. |
Customer |
| 4 |
Greenlight Guru shall input the provided design controls into the customer’s Greenlight Guru production environment. |
Greenlight Guru |
| 5 |
The customer shall meet with Greenlight Guru for a summary of the completed work. |
Customer and Greenlight Guru |
Timeline: Customer has 120 days to meet with Greenlight Guru to plan the migration and provide the design control traceability matrix. If the matrix has not been received or the meeting has not been held, the services are considered delivered and are no longer redeemable. Greenlight Guru has 90 days to complete the services after the meeting has been held and Greenlight Guru has received the design control matrix from the customer.
Guru Implementation Services: Risk Management Migration
Deliverables: The current version of the customer’s risk assessment will be added to the customer’s Risk Management workspace.
- All provided Hazards, Foreseeable Events, Hazardous Situations, and Harms will be added and linked together.
- The initial and residual probability and severity for each risk line will be added as provided in the customer’s risk assessment.
- Risk Controls and Control Verifications can be included if the associated Design Controls have already been entered into the customer’s Project workspace, or the customer would like to complete Risk Controls without a link to Projects.
- Related Items, Attachments, Benefit-Risk Analysis, and Risk Acceptability are not included in this service.
| Step |
Task |
Responsibility |
| 1 |
The customer shall provide their existing risk assessment. |
Customer |
| 2 |
The customer shall meet with the Guru to plan the translation of the customer’s existing risk assessment to the Greenlight Guru Risk Management workspace, including column mapping, Risk Categories, Risk Acceptability Matrix, Risk Control and Verification method, and Hazard and Harm configuration. |
Customer and Greenlight Guru |
| 3 |
The customer shall provide Greenlight Guru access to their Greenlight Guru production environment. |
Customer |
| 4 |
Greenlight Guru shall input the provided risk assessment into the customer’s Greenlight Guru production environment. |
Greenlight Guru |
| 5 |
The customer shall meet with Greenlight Guru for a summary of the completed work. |
Customer and Greenlight Guru |
Timeline: Customer has 120 days to meet with Greenlight Guru to plan the migration and provide the risk assessment. If the matrix has not been received or the meeting has not been held, the services are considered delivered and are no longer redeemable. Greenlight Guru has 90 days to complete the services after the meeting has been held and Greenlight Guru has received the risk assessment from the customer.
Guru Implementation Services: QMS Template Completion
Deliverables: A Medical Device Guru will complete the company-specific green text within Phases 1-4 of the purchased Greenlight Guru QMS templates, and upload the completed templates into the customer’s Greenlight Guru production environment.
- Template completion includes adding the customer provided company logo to each of the templates, including the Forms, as well as filling in the green text within the Quality Manual, Procedures, and Work Instructions.
- Attributes and Values will be configured in the customer’s Greenlight Guru environment to set up an organizational structure for the documentation.
- Customer is required to purchase the Greenlight Guru QMS templates.
- Customer shall use the Greenlight Guru defined document nomenclature.
- Completion and upload of software specific templates are not included as part of this service.
| Step |
Task |
Responsibility |
| 1 |
The customer shall meet with Greenlight Guru for an overview and information intake call. |
Customer and Greenlight Guru |
| 2 |
The customer shall fill out an intake form with the company-specific information needed to complete the QMS templates. |
Customer |
| 3 |
The customer shall provide Greenlight Guru access to their Greenlight Guru production environment. |
Customer |
| 4 |
Greenlight Guru shall complete the company-specific green text within Phases 1-4 of the purchased Greenlight Guru QMS templates, and upload the completed templates into the customer’s Greenlight Guru production environment. |
Greenlight Guru |
| 5 |
The customer shall meet with Greenlight Guru for a summary of the completed work. |
Customer and Greenlight Guru |
Timeline: Customer has 120 days to meet with Greenlight Guru to introduce the project and complete the intake form. If the intake form has not been completed or the meeting has not been held, the services are considered delivered and are no longer redeemable. Greenlight Guru has 90 days to complete the services after the meeting has been held and the customer has completed the intake form.
- Updated Feb 2024 -
