What is a change control document?
A change control document has to be a systematic and sequential entry of data supporting change in a project. It goes through an initial process of change request, through the process of change approval or denial and finally with change implementation, if it is approved.
What is a best practice for change control?
A good Change Control system should:
Identify the needed change. Justify the change. Evaluate the impact on the organization. Document the change.
Why is change control needed?
Change control is an important part of the project management process. The change control process helps avoid unnecessary changes that might disrupt services and also ensures the efficient use of resources.
Planning and managing a project involves so many elements that cannot be all included in one article. However, they can be grouped under three major categories: Product, People and Process.
The change management process itself consists of three phases: the preparation, planning and execution phase.
Assign a number to uniquely identify each change request. Change description: This is a brief description of the change that's been requested. Change reason: Provide an explanation for why the change has been requested. Discuss the reason for the change with your stakeholders, and document their words.
The change request form is the primary tool used for requesting, approving, and documenting changes to the project and is an important piece of the change management process.
Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. Certain manufacturing changes (i.e changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.