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Pharmaceuticals, healthcare and FMCG are few of the industries which need to meet stringent guidelines of various quality and regulatory authorities. FDA defined CGMP for each one of them to ensure that the end consumers are getting superior value. OOS & OOT management becomes important here.
Each and every step should be recorded systematically according to the current good manufacturing practice (CGMP) so recording and investigating out-of-specification (OOS) and out-of-trend (OOT) in also an essential part of quality management practices.
Before explaining ahead lets understand OOS & OOT management.
Out-of-specification (OOS) – comparison of one result versus a predetermined specification criteria.
Out-of-trend (OOT) – comparison of many historical data values versus time.
As per FDA guidance in Pharma industry investigating out-of-specification test results should be handle systematically so testing of API (Active Pharmaceutical Ingredients), excipients and other components and finished drug products sometimes results in an out-of-specification. This should be be reported and investigated as recommended by the guidance from Regulatory Authorities. The amount of time required for retesting and resampling can cause to delay in product launch and failure. So to save time the need of OOS & OOT software is very much required.
QEdge OOS & OOT management software has been specially developed after an extensive research on OOS guidelines from various regulatory agencies, streamline and automate the whole recording and investigation approach like retesting, resampling, batch rejection, release through phase wise investigation and CAPA. QEdge OOS & OOT management software empowers an organization to reduce OOS reporting time, evaluate for its repetition, easy access of previous records/ summary reports and disintegrate investigation into multiple tasks such as Re-analysis tasks, re-sampling tasks, review tasks that can be assigned, completed and tracked.
QEdge allows you to electronically record OOS and OOT with ability to store and retrieve related document easily as per your need.
QEdge also offers in-built flexibility to design and implement the system in such a way, that in-between processes and workflow within the organization can be customized under generic OOS and OOT management software solution.
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