In order to provide assurance that items are sterile, the SSD must monitor every stage of the process.
Validation is an essential part sterility assurance. Validation is basically being able to prove beyond doubt that the equipment works and that the department can repeatedly produce sterile products by using a proven system which includes quality control measures.
The LTrace software is designed to assist in the recording of results as well as, where possible, ensuring that a process is followed. It is critical to remember that LTrace can not provide assurance on its own. It relies on staff having good procedures and that they follow them.
In particular, there are no substitutes for visual inspection and common sense. The LTrace system should not distract staff from inspecting items nor using common sense to handle emergencies and exceptions to the rule