Change Control

Question 1

Change Responsible (role/responsibility)

Answer 1

Decide how to document the change, according to this document.
Ensure that all changes are considered in relation to impact on release of
Products.

Question 2

QA approver (role/responsibility)

Answer 2

Ensure understanding of the change and be part of the decision of when
and if a change can be executed.

Question 3

Change Responsible (role/responsibility in novoGloW)

Answer 3

Prepare and plan the change.
• Ensure impact and risk assessment, as required.
• Manage the execution of the change ensuring timely completion.
• Evaluate the executed change according to the defined criteria.
• Ensure compliance with this document

Question 4

QA approver (role/responsibility in novoGloW)

Answer 4

Verify compliance with this document when approving changes.
• Approve changes for execution.
• Approve evaluation of changes.
Major flow: Approve completion of execution
Regulatory impact: Define criteria for batch limitation.
• Remove batch limitation when requested by releasing QA.

Question 5

RA reviewers (role/responsibility in novoGloW)

Answer 5

Provide an RA assessment when requested by the Change Responsible.
• Provide an RA conclusion for Change Requests with regulatory impact.
• Mark Change Requests in novoGloW, when their RA conclusion is
changed after approval.

Question 6

When to use novoGloW to document a change and when to use another system e.g other IT systems, logbooks, document change logs or IT metadata.

Answer 6

Examples on both in Q220205, Change Control, page 4-6. If in doubt use novoGloW

Question 7

Change Request process in novoGlow

Answer 7

Picture

Question 8

A change can only be executed after

Answer 8

QA approval

Question 9

Both Change Responsible and QA approver role that perform the steps in the process can be reassigned during the entire lifecycle of the Change Request

Answer 9

Note! Be aware that reassignment is important as Employees assigned to a Change Request are the only ones able to route the case from one phase to another.

Question 10

Criticality, Major flow

Answer 10

For changes following major flow, perform a risk assessment of the change

Question 11

Criticality, Minor flow

Answer 11

A formal risk assessment is not required for changes that follow the minor flow as these changes are assessed as ‘low-risk changes’. Supporting documentation assessing risk can, however, still be attached to the Change Request.

Question 12

Define the deadline for the execution – major flow

Answer 12

Remember to include time for QA to approve the completion of the execution

Question 13

Evaluation of Change Requests in novoGloW

Answer 13

All Change Requests in novoGloW must be evaluated after the change is executed to ensure that the change is implemented as intended.

Question 14

When can an input be requested

Answer 14

Input can be requested at any point up until the approval of the Change Request for execution. When requesting input, remember to state the role or responsibility of the person providing the input in relation to the change/input.

Question 15

Before sending for the Change Request for approval

Answer 15

Ensure that the Change Request complies with this document and send the Change Request for QA approval.

Question 16

Execute the Change

Answer 16

The Change Responsible is overall responsible for managing execution of the change. The deadline for execution can be extended in agreement with the QA approver.

Question 17

Completion of execution

Answer 17

Minor Flow: Change Responsible - Send the Change Request to the Evaluation phase. Major Flow: Change Responsible - Send the Change Request for QA approval: ‘Execution completed’.

Question 18

Implementation date

Answer 18

The date when the execution of the Change Request is completed is called the implementation date. This date is automatically recorded in novoGloW once the Change Request is moved into the ‘Evaluation’ phase.

Question 19

Evaluation

Answer 19

Change Responsible – Document evaluation. QA – Verify the evaluation performed by the Change Responsible and provide a conclusion and approve the evaluation.

Question 20

Completed Change Request

Answer 20

Change Request is completed when the QA approver approves the evaluation. A completed Change Request is archived and closed by novoGloW.

Question 21

Extend deadlines. Deadlines for the Execution and for the Evaluation of the change can be extended in agreement with the QA approver.

Answer 21

Change Responsible - Create an extension request in novoGloW, Define the new proposed deadline, Justify the need for extension. QA - Verify that the extension is justifiable and that it does not have a negative impact on the planned execution and desired outcome of the change. Select the outcome of the extension request: accepted or rejected.

Question 22

Cancel a Change Request

Answer 22

Change Request can only be cancelled in the phases ‘New’ or ‘Execution’. In the ‘Execution’ phase, the cancellation requires QA approval. Change Requests in the Evaluation phase cannot be cancelled.