| There is no doubt that life science companies are | | | | life science companies are surely "losing out" on |
| highly regulated. Between the FDA, ISO, EMEA | | | | changes that should occur. This aspect of an |
| (Europe), CLIA and additional regulatory organizations, | | | | employee's duties are so important in fact that |
| life science companies are struggling to keep | | | | employees should not even be hired without |
| everybody happy. Though motivated by good | | | | determining whether or not they can provide clear |
| intentions however, life science companies' efforts to | | | | written and/or verbal communication in a change |
| meet every regulation are actually counterproductive, | | | | control context. To determine this ability, employees |
| since---like the unwise high school student---they are | | | | could be tested quickly by asking them to write a |
| striving to "pass the test" without "learning the | | | | change control request justification after they had |
| material." | | | | been given a hypothetical "big picture" scenario and |
| Getting Back in Control | | | | asked to relate their justifications to the immediate |
| Life science companies need to realize that | | | | effects that the change would have on the overall |
| regulations are designed not to push companies into | | | | purposes specified in the scenario. |
| an oblivion of confusion but are actually designed (or | | | | "Document the Change" |
| at least should be) with the intent of getting | | | | Documenting change control requests and |
| companies to think about the "big picture" or the | | | | justifications is fairly straight forward. The FDA |
| purposes of their own company projects. | | | | regulations and/or directives specify a good amount |
| Take change control processes for example. Change | | | | of the information that should be contained on |
| control processes can get tricky. When a company | | | | change control requests and/or additional change |
| has a thousand or more annual requests for change | | | | control related information. |
| and has to make sure that once approved these the | | | | Controlling the ebb and flow of change control forms |
| requests are put into action and effectively resolved | | | | and documentation however can be a bit complex. In |
| closed, while simultaneously maintaining, tracking and | | | | fact, managing any type of compliance |
| archiving all related documentation, it's no wonder | | | | documentation is often the monster of compliance in |
| that change control processes the world over still | | | | general. However, current technology has resolved |
| give the FDA enough reason to hand out change | | | | many of the issues involved with both company wide |
| control related 483s like candy on the 31st of | | | | change control process management and |
| October. | | | | documentation change control. Life science QA |
| Taken at a simplified level however, change control is | | | | members and other professionals for example should |
| actually beautifully simple. | | | | search for a software solution/system that allows life |
| Change Control Simplified | | | | science companies to automate tasks and processes |
| The FDA for instance outlines the simplicity of the | | | | associated with change control, company wide |
| control of change in an article entitled, Change | | | | documentation (including change control related |
| Control: Best Practices For FDA-Compliant Medical | | | | documentation) and compliance. |
| Device Manufacturers, when it states that "At its | | | | "Get all Necessary and Appropriate Approvals" |
| most basic, change control is really just common | | | | Those groups assigned to approve change control |
| sense. There are six steps to this very important | | | | requests should 1) be large enough to stimulate |
| process:o Identify the needed change;o Justify the | | | | various opinions and 2) should include at least one or |
| change;o Document the change;o Get all necessary | | | | two individuals with significant change control |
| and appropriate approvals;o Communicate the change | | | | experience. Approval groups should also have a deep |
| and train all the people who are affected; ando | | | | understanding of the "big picture" as should most |
| Implement and evaluate it afterward" | | | | employees but in addition should also have an even |
| Yeah Right! | | | | deeper sense of change applicability and change |
| Yeah. Easy for the FDA to say right? They are not | | | | prioritization. The question of applicability is often |
| the ones who have to implement the change control | | | | resolved via open conversation with other approval |
| system. However, isn't there comfort in the fact that | | | | members and prioritization levels and changes should |
| the FDA has only provided a brief and very general | | | | be documented well on SOPs and should always be |
| outline for change control processes and that it is the | | | | adhered to by approval members. Prioritization of |
| life science companies themselves that get to fill in all | | | | change control request processes may and should go |
| of the blanks? Some companies might wish the FDA | | | | through a variety of changes as company priorities |
| would be more specific but then how would the | | | | change. |
| learning occur? | | | | "Communicate the Change and Train All the People |
| This article should help companies fill in the change | | | | who are Affected" |
| control blanks by providing outlines for success in the | | | | Communication of a change can occur quickly via a |
| FDA template: | | | | software solution(s) such as the system mentioned |
| "Identify the Needed Change" | | | | above. Training processes as well can be managed |
| First and foremost, employees need a greater | | | | electronically. However, the most important aspect of |
| understanding of the company projects to which | | | | training is to constantly emphasize the "big picture"or |
| they are assigned. When they are assigned to a | | | | main purposes of a project. |
| specific department for instance, they need to | | | | Implement and Evaluate it Afterward |
| understand the overall "big picture" of the | | | | The implementation and evaluation of changes should |
| department's goals and most likely the company's | | | | be carefully and conscientiously monitored. To save |
| goals as well. Department managers must ensure | | | | time and to eventually save revenue, life science |
| that initial and continuing change control training | | | | companies should invest in a system that will not only |
| includes project focused information that will not only | | | | manage change control and document control |
| improve change control results but will give | | | | processes but that will track and maintain all of the |
| employees the sense that they are trusted enough | | | | data associated with the changes themselves. The |
| to participate. | | | | system should also have reporting capabilities so that |
| "Justify the Change" | | | | data can be viewed and analyzed scientifically. |
| Justifying the change is often left to the employee | | | | Conclusion |
| or employees that identified the potential need for a | | | | To effectively control a change control process, life |
| change in the first place. Justification of a change is | | | | science companies need to focus on the purpose or |
| an extremely important aspect of controlling change | | | | the big picture of life science projects and also need |
| processes. If the initiator of the change cannot | | | | to search for solutions that will automate many of |
| elucidate why he or she believes the change should | | | | the processes associated with change control. |
| occur in the overall context of the big picture then | | | | |