The Three Categories

We’ve divided the benefits of change control into three categories:

• Regulatory
• Business
• Safety

For regulatory compliance, it is critical to outline the requirements for change management and control for the record and documentation of changes authorized by the Quality Unit.

Regulatory Requirements

Following the regulatory requirements and guidelines provides protection from changes that could affect the quality and integrity of the product.

Consequently, the FDA mandates change control as a requirement of compliance with regulations.

In fact, change control consistently ranks in the top 10 reasons for FDA 483 observations.

Ultimately, a change control procedure ensures the quality of a product.

Changes to business practices should undergo the change control process to ensure that resources and finances are not detrimentally affected by the change.

Strategic Goals

The change control process also allows for evaluation of whether or not the change is aligned with business practices and strategic goals.

Change control assesses all risks (including safety) and provides for controls to ensure the safety of operators and safety of the end user or patient.

A change with a high impact on safety will have the opportunity to be assessed for benefit/safety impact.

Process Reliability

The change control monitors all categories of changes that can influence the process reliability or product quality, evaluates them in reference to the relevant established regulatory requirements, and determines the measures necessary for implementing the change, or decides that a change should not be implemented.

Therefore, change control ensures that a system remains in its suitable state of control throughout product lifecycle and involves the entire company.

Now that we have a better understanding of change control basics, let’s turn our attention to US regulations on change control.