Navigating Change Control in Software Validation for Life Sciences

Change control requirements ensure that drugs and devices stay safe for patients as manufacturers update their systems. But the process can be complicated.

Traditional document-centric computer system validation processes often involve creating lengthy test scripts and numerous screenshot attachments. But, this approach is labor-intensive and slows down timelines.

Identifying Changes

How is computer systems validation done? When a change is required, it must be evaluated by a designated team and prioritized based on impact. This includes members from IT and OT technical experts, engineering, users, maintenance, quality assurance, and validation (GxP).

All potential changes must be entered into a change control system to begin the evaluation process. This includes a description of the change, its impact, and how it will be implemented. Once the initial evaluation has been completed, it will be determined if the difference qualifies as a minor or major one. If a change is deemed significant, it must go through the entire review process for approval, including testing and documentation.

This can be a difficult task, especially if your company is not using an automated process to manage change. Changes often happen quickly in the life sciences industry, so it is essential that the correct personnel brings up any changes that need to be evaluated and that they are logged as quickly as possible.

In addition to quickly identifying and prioritizing changes, the software used for change management should also make it easy to distribute these documents to the appropriate reviewers, allow for live comments and discussions about the change, and provide a clear redlining option to highlight any areas of concern. This will save your company time and help the review process move more efficiently.

Creating a Log

Once a potential change is identified, it should be entered into the shift log with a unique identification number. This will allow stakeholders to find specific requests when searching for them and ensure they communicate about the correct request. It will also make it easy to determine which changes impact the same area of your system.

You should also record the change date, the status (e.g., approved, denied, or waiting for review), and the impact on the project. This will give stakeholders a complete picture of the changes and how they affect the project.

When you are done creating a change log, it will be possible to import the spreadsheet and display all of the information in a Gantt chart view. This will make it easier for everyone to track the progress of the changes as they are implemented and minimize any back-and-forth communication.

Creating a change log will be one of the most critical steps in your process. This will not only help you manage the project more effectively, but it will also improve the overall quality of your work. It is also critical that you communicate with your team regularly about any changes that are being made, including how they will affect the project and what steps need to be taken to mitigate any potential issues.

Creating a Change Report

Throughout the change control process, all activities should be documented. This can be done with a simple spreadsheet or, for a more complete view of what is happening, a software system specifically designed to manage this type of activity. This allows all team members to be quickly informed as the change progresses. It also enables the Quality Representative to determine the impact of the change and what notifications are needed, which may include notification to clients and third parties and internal company requirements.

Any risks identified must be reviewed continuously as the change process progresses. This will help ensure that the risk assessment at the end of the change is accurate and reflects any additional information gathered from the validation/verification activities. This is one of the reasons why a software system designed to manage change can be so valuable, as it eliminates the need for manual, time-consuming spreadsheet calculations and can provide a real-time picture of the change status in an easy-to-understand format.

Life Sciences companies must have a formal process in place to handle changes to their systems. Failure to do so could have devastating unforeseen consequences. The dangers of unmanaged change are real, from missing clinical trials to faulty equipment, incorrectly assembled products, and miscalculated tolerances. Organizations can minimize these dangers and maintain regulatory compliance by using a validation management system purpose-built for the Life Sciences industry that bakes GxP disciplines into its workflows.

Documenting Changes

When a pharmaceutical or medical device company changes its systems, it must document evidence. This evidence must show that the new software, spreadsheets, or design works in a way that protects patient or consumer product quality and data integrity.

The level of documentation needed depends on the size and impact of the change being made. Most changes will need to go through an entire review process and be evaluated based on the effect that they may have. The impact could be anything from a change in equipment to changing the location of a manufacturing site. These significant changes will often require additional work with regulators or the notified body, if applicable, to ensure the change has been approved.

Once the change has been evaluated, a new system version must be created. This can be accomplished using automated test scripts or manual testing. The computerized approach is usually preferred because it can save significant time. In the past, life science companies have often found that their validation efforts have been slowed because each time a vendor releases an upgrade, they must create a new set of tests and update the test scripts.

Fortunately, some vendors are working to help life science organizations navigate this challenge by providing software solutions that are purpose-built for the industry and bake GxP disciplines into their software. This can enable a faster, more accessible, and more comprehensive FDA validation process.