Common Sense Change Control in Regulated Life Science Environments

There is no doubt that life science companies are highly regulated. Between the FDA, ISO, EMEA (Europe), CLIA and additional regulatory organizations, life science companies are struggling to keep everybody happy. Though motivated by good intentions however, life science companies\' efforts to meet every regulation are actually counterproductive, since---like the unwise high school student---they are striving to \"pass the test\" without \"learning the material.\"

Getting Back in Control

Life science companies need to realize that regulations are designed not to push companies into an oblivion of confusion but are actually designed (or at least should be) with the intent of getting companies to think about the \"big picture\" or the purposes of their own company projects.

Take change control processes for example. Change control processes can get tricky. When a company has a thousand or more annual requests for change and has to make sure that once approved these the requests are put into action and effectively resolved/closed, while simultaneously maintaining, tracking and archiving all related documentation, it\'s no wonder that change control processes the world over still give the FDA enough reason to hand out change control related 483s like candy on the 31st of October.

Taken at a simplified level however, change control is actually beautifully simple.

Change Control Simplified

The FDA for instance outlines the simplicity of the control of change in an article entitled, Change Control: Best Practices For FDA-Compliant Medical Device Manufacturers, when it states that \"At its most basic, change control is really just common sense. There are six steps to this very important process:

Identify the needed change;

Justify the change;

Document the change;

Get all necessary and appropriate approvals;

Communicate the change and train all the people who are affected; and

Implement and evaluate it afterward\"

Yeah Right!

Yeah. Easy for the FDA to say right? They are not the ones who have to implement the change control system. However, isn\'t there comfort in the fact that the FDA has only provided a brief and very general outline for change control processes and that it is the life science companies themselves that get to fill in all of the blanks? Some companies might wish the FDA would be more specific but then how would the learning occur?

This article should help companies fill in the change control blanks by providing outlines for success in the FDA template:

\"Identify the Needed Change\"

First and foremost, employees need a greater understanding of the company projects to which they are assigned. When they are assigned to a specific department for instance, they need to understand the overall \"big picture\" of the department\'s goals and most likely the company\'s goals as well. Department managers must ensure that initial and continuing change control training includes project focused information that will not only improve change control results but will give employees the sense that they are trusted enough to participate.

\"Justify the Change\"

Justifying the change is often left to the employee or employees that identified the potential need for a change in the first place. Justification of a change is an extremely important aspect of controlling change processes. If the initiator of the change cannot elucidate why he or she believes the change should occur in the overall context of the big picture then life science companies are surely \"losing out\" on changes that should occur. This aspect of an employee\'s duties are so important in fact that employees should not even be hired without determining whether or not they can provide clear written and/or verbal communication in a change control context. To determine this ability, employees could be tested quickly by asking them to write a change control request justification after they had been given a hypothetical \"big picture\" scenario and asked to relate their justifications to the immediate effects that the change would have on the overall purposes specified in the scenario.

\"Document the Change\"

Documenting change control requests and justifications is fairly straight forward. The FDA regulations and/or directives specify a good amount of the information that should be contained on change control requests and/or additional change control related information.

Controlling the ebb and flow of change control forms and documentation however can be a bit complex. In fact, managing any type of compliance documentation is often the monster of compliance in general. However, current technology has resolved many of the issues involved with both company wide change control process management and documentation change control. Life science QA members and other professionals for example should search for a software solution/system that allows life science companies to automate tasks and processes associated with change control, company wide documentation (including change control related documentation) and compliance.

\"Get all Necessary and Appropriate Approvals\"

Those groups assigned to approve change control requests should 1) be large enough to stimulate various opinions and 2) should include at least one or two individuals with significant change control experience. Approval groups should also have a deep understanding of the \"big picture\" as should most employees but in addition should also have an even deeper sense of change applicability and change prioritization. The question of applicability is often resolved via open conversation with other approval members and prioritization levels and changes should be documented well on SOPs and should always be adhered to by approval members. Prioritization of change control request processes may and should go through a variety of changes as company priorities change.

\"Communicate the Change and Train All the People who are Affected\"

Communication of a change can occur quickly via a software solution(s) such as the system mentioned above. Training processes as well can be managed electronically. However, the most important aspect of training is to constantly emphasize the \"big picture\"or main purposes of a project.

Implement and Evaluate it Afterward

The implementation and evaluation of changes should be carefully and conscientiously monitored. To save time and to eventually save revenue, life science companies should invest in a system that will not only manage change control and document control processes but that will track and maintain all of the data associated with the changes themselves. The system should also have reporting capabilities so that data can be viewed and analyzed scientifically.

Conclusion

To effectively control a change control process, life science companies need to focus on the purpose or the big picture of life science projects and also need to search for solutions that will automate many of the processes associated with change control.

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to the implementation of a change control software system, please contact a MasterControl representative.

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