21 cfr part 11 compliance checklist
Thus, companies in the health sector have increasingly invested in the automation of processes and the use of electronic records to replace paper. Such change guarantees the integrity of the information generated through automation. In other words, they must always represent reality, inviolable and stored in a secure environment, in addition to being produced automatically and free from any flaws. However, to validate the system, it is necessary to observe if it has some important characteristics, such as: Individual access with login; Password for time control of sessions; Protected data; Possibility to copy the data or print it; Have a password recovery or change policy that allows for an audit. These are essential items that need to be in the system. This ensures that the validation will be effective. Qualification of systems Qualification is an important pr ocess when validating systems. It is the sum of actions created to document and at...