The term out of specification (OOS), is defined as those results of in process or finished product testing, which falls out of specified limits that are mentioned in drug master file (DMF), or drug application. The OOS, may arise due to deviations in product manufacturing process, errors in testing procedure, or due to malfunctioning of analytical equipment or others. Whereas out of trend (OOT) is the comparison of historical data versus time.
Sarjen’s QEdge eQMS provides OOS and OOT to handle different scenario, fishbone analyses; 5 Whys analyses (5 is a manageable number to get to the bottom of the appropriate root cause but can go deeper) – to analyse problems, root causes, allowing users to identify actual problems & contributing factors rather than apparent indications; and rectifying the same.
And, also has ability to store and retrieve related document as well as complete link with resulting outcome in terms of change control or CAPA or other quality processes.