The goals of any life science company should include the development, manufacture and sales of the best and most useful biotech equipment, medical devices, drugs, and other products. The goals of the FDA, however, include safety, the transparent communication of possible dangers or uncomfortable side effects, and the viable effectiveness of products produced. Each set of goals, in theory, supports the other. In practice however, they almost seem mutually exclusive.
Like most solutions to diametrically opposing problems, the solution that benefits both organizations has to include the implementation and use of change management software. These applications are valuable because it allows life science companies to easily those changes that can occur at any stage of the development or manufacturing processes.
Among the problems that many life science companies face are the change management processes that are controlled manually or with a hybrid/decentralized solution. Most companies simply want to increase their ROI, but, in truth, neither manual or hybrid solutions won’t save them money in the long run and can present a variety of difficult problems.
Life science professionals may think they save money with a paper-based system but in reality the tedious man-hours spent on the routing of documents, the document approval process and on search and document retrieval can cost the company even more. Change management software, however, manages to automatically route documents, seek the appropriate approvals or electronic signatures, and search for and retrieve documents.
The FDA requires that processes (including change processes) are validated. Validating a process manually can be a far greater challenge than some companies realize. Electronic validation offers a more effective alternative that saves time and money, whereas manual validation can easily cost more than a centralized solution.
A paper-based system doesn’t allow life science professionals to maintain, protect and organize documents in one centralized location. A quality change management software solution digitizes and centralizes information so that associates can find the information they need, when they need it. A good change management software solution will also control almost any type of file required throughout any of the GxP processes.
Change always happens, and the manual document revision process can be hard to implement. Life science employees are often subjected to manual searches for documents, and will be required to manually make changes on documents or SOPs. A good change management software solution, though, can provide automatic and centralized control so that a submitted document can be routed and approved quickly and effectively.
When you are searching for the change management solution that will fit your needs, look for a solution that is customizable and that require form explanations for changes that are made. Accountability is one of the most important aspects of change control. Change control can take life science professionals one step further and develop the processes that will take the company to the next level.
Huntingdon Life Sciences is one of the world’s largest contract research organizations, providing a comprehensive range of non-clinical development services with 50 years of history. Huntingdon Life Sciences is a UK based contract research company. It specialises in biological, agrochemical and pharmaceutical.
