A prerequisite for a functioning pharmacovigilance system are appropriate standard operating procedures, based on which personnel know what needs to be done and when. One and the same standard operating procedure does not work in every company.

When preparing the instructions, it is good to keep in mind why something is being done, who is doing it and how. In a small company, there are not enough workers for a multi-step process like in a larger company, and there is no need for it. Good standard operating procedures are made possible by listening to the customer, understanding the quantity and quality of the systems in use, the company’s resources and products, and knowledge of the requirements of the law.