GxP Lifeline Feature Article

How to Solve the Top Five Change Control Challenges


Solutions for the Most Common Change Control Issues Faced by Life Science Companies

If the ancient Greek philosopher Heraclitus were alive, he would probably be pleased to know that today there is such a thing as “change control.” Heraclitus once said: “Nothing endures but change.” He was right. And for life science companies, change must be managed not only because it’s inevitable but also because uncontrolled change could affect product safety and quality.

Under the FDA’s GxP requirements, a change control system is necessary to prevent inappropriate modifications. While this sounds simple, implementation can be difficult. Here are five common change management issues that companies often complain about and some tips on solving them. 

1. Inefficient System of Communication. You need effective communication to be able to implement change properly. For a company that relies on a paper-based or partially electronic system, this is the typical scenario: Once or twice a week, up to 15 people who constitute the Change Control Board meet for two hours each time to discuss engineering and other document changes. Before and after each meeting, documents are routed using the inter-office mail system or via e-mail. The problem with this scenario is that everything depends on the availability and the willingness of the members to meet.

Change Control Process Solution: With an automated change control system, you can say goodbye to twice-a-week meetings because all tasks pertaining to change control can be routed electronically. Choose a Web-based system, so even if your team members are out of the office or out of town, they can still participate through the Internet. Better still, choose a system with FDA-compliant electronic signature capability, so your approvers can sign documents at their convenience. With an automated system, you can save meetings for emergency changes.

2. System Plagued by Delays.  In today’s competitive market, change delayed is opportunity-for-success wasted. Companies that rely on a manual system to generate data and to route and track change orders are likely to be plagued by delays because everything requires more time and effort. The problem becomes worse when there is an unexpected change, and supporting data is not generated in a timely manner.

Change Control Process Solution: By switching to an automated system, submitting change requests, routing change orders, and tracking changes will all be done electronically, and more efficiently. Choose a system that requires users to evaluate the change in terms of the training and validation needed and other regulatory requirements to help you assess risks. Your system should also require users to categorize a change submission as routine or temporary or emergency for prioritization.

3. Ineffective Documentation. A paper-based system requires vigilance in revising and updating documents, something that is hard to expect from all users all the time. The result: ineffective documentation. For example, implementation of a proposed change is delayed because an outdated record does not show revision history, or testing is inadvertently duplicated, wasting time and effort, because documentation has not been updated with results of a previous testing.

Change Control Process Solution: Automate your documentation and reporting functions for increased efficiency and effectiveness. Select a change control solution with a robust history revision feature that will show all changes made to a document and the corresponding reasons for each change. To ensure compliance with 21 CFR Part 11, find a solution that offers time-stamped audit trail that will document the identity of anyone who creates or modifies an electronic record, when it happened, and the changes made.

4. Training Not Integrated with Change Control. Adequate training of personnel is a prerequisite in the FDA environment. When training control is not connected to the change management process (such as in a paper-based system), keeping training current with procedures that have changed can be difficult. Training tasks can easily fall through the cracks if employees are not vigilant in seeking them.

Change Control Process Solution:  In choosing change control software, scrutinize the system’s capability to integrate training. The benefits of an integrated system are enormous. Instead of manually reconciling engineering changes, revised SOPs, and other documents with who needs to be trained on them, an integrated system will do the checking for you. Any change to a document or process that warrants new training will automatically invoke training tasks. If possible, pick an electronic solution capable of distributing and grading online exams.

5. Lack of Secure, Centralized Repository. To implement change, you need supporting data, but finding what you need in filing cabinets and storage rooms is time-consuming. It often results in poor turnaround for change implementation. With more and more companies merging and going global, it is also likely that records are scattered in different places. The implications are serious not only in terms of efficiency, but also security.

Change Control Process Solution: You can store all change control records in a centralized electronic repository, making it easier to update, and search and retrieve them. A Web-based system will give all authorized users in different locations easy access. Even suppliers and others outside of the company who are part of the change control process can have access. You can limit their access based on the extent of their participation. Pick a system that offers FDA-compliant security features covering such areas as user authentication, record retention, and audit trail.


Read more about the importance of optimizing the change control process:

White Paper:
Change Control - Quality Improvements in FDA and ISO Environments

White Paper:
Automating Electronic Engineering Change

Tech Paper:
MasterControl Change Control™



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FDA Link

  • Quality System Regulation Manual, Document and Change Control Procedure
    Full Article

Additional Article

  • Document and Change Control in the Design Process (Medical Device)
    Full Article