Resources for FDA Compliant Change Management

Resources for FDA Compliant Change Management

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Like the corrective action process, the change management process is a central part of your quality management system. Change is difficult to manage because it touches every area of your business (including suppliers) because it is constant, and because the process to manage it needs to be compliance-driven. If you already have a change management process in place, here are some resources to help you understand areas where your process can be more harmonized, compliant, and efficient.

Tell the whole story about each change.

This Q&A on FDA compliant change management provides insight into better managing impact assessment and documentation of a change. These areas are typically weak in most change management processes. The article points out that change documentation is often weak or incomplete because there is an internal assumption that “everyone knows what is going on.” When an auditor or other third party later reviews the change, the record seems incomplete because it doesn’t tell the full story. This can make the process seem less thorough or compliant than it actually is.

A bonus pointer from this article is to be on the lookout for the cumulative effects of minor changes or the effect that multiple changes may have (cumulatively) on product quality.

Some changes require regulatory notifications.

Design changes, for example, may require notifications to the FDA. Is there a review for this type of notification within your change management process? Some simple advice: “If the design change impacts form, fit, or function and/or the intended use of the finished device is changing or being expanded, then rest-assured, the agency is going to want to know about it.” Read here for further insight and common sense pointers on this topic.

Harmonizing change can be tricky, but it can be done.

If you’re manufacturing and selling products around the globe, managing change gets even trickier and more complex. Harmonizing processes, especially the change process, is always a relevant topic. This presentation on harmonizing change control processes globally will help you think about the scope of your change control process, roles that individuals should play in a global process, and how changes and change processes at various sites are connected.

Hint: Skip ahead to the middle of the presentation (slide 28 and beyond) to get to this information quickly!

Your ability to control change impacts time to market.

This article covers the basics of change control and its importance. While the main objective is covering the fundamentals, it emphasizes that the efficiency of the change process ultimately impacts time to market. An inefficient change process will ultimately slow time to market and put you behind the competition. The focus here is on better communication and proper training to ensure that change is efficient and controlled.

Communication is the key to FDA compliant change management.

Change impacts every part of your organization including documents, facilities, equipment, products, processes, and more. It is impossible to anticipate every change that may occur or all of the areas that change will affect. However, there are detailed guides to change control, such as this Practical Guide to Change Control Systems Management. It provides detail on how to manage numerous types of change in a compliant manner. One key takeaway from this detailed document is that both communication and a culture of quality are essential to maintaining an FDA compliant change management process.

Additional resources:

There are additional resources on the Pilgrim blog to help you understand FDA compliant change management and how to keep it under control. You can learn:


Managing Change the Smart Way: SmartSolve

5-Minute Overview Video

SmartSolve® Change Management enables you to develop a harmonized and efficient change control process. Watch this short video to learn how Change Management can help your organization manage change effectively.

managing change


Pilgrim’s automated SmartSolve® Change Management software also helps Life Sciences organizations implement an efficient, FDA-compliant change control process. Watch our 5 Minute Video to learn more.

What are your top change management challenges? Let us know in the comments below.

Roxane Napoli

Senior Marketing Manager, Pilgrim Quality Solutions

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