How Do You Write Standard Operating Procedures?
Standard Operating Procedures (referred to as SOPs) is a significant tool and a requirement for most operating in a regulated industry. The main reason for this is in the government do not like to be too specific about how you do business. They prefer writing broad requirements and letting you decide how you are going to abide by the regulation. You are expected to do this by creating written and approved procedures. For example, the regulation require that a company conduct a clinical trial with adequate resources and individuals qualified by training and experience. Now it is up to the company to write procedures identifying what “adequate resources” mean to that company. They should also identify what they consider as “qualified by training”. Does one training session mean that person is trained? Or do they need 2 or 3 training sessions before they are deemed adequately trained. Now, that you understand what the SOP process is about and why you need them, I’ll give you a few tips on
