Deviation Management (DM)

Oasis deviation management tool helps capture defects and assess their risk. OasisLIMS simple deviation reporting option lets you quickly capture details like part, quantity, failure type, and severity.

With this module, you initiate and document planned and unplanned deviation with supporting documentation, define root-cause of deviation, evaluate and investigate to analyze risk at any point in the process with initial and final risk assessment, resolve problems quickly, keep every department in a loop and optionally integrate and escalate with CAPA Management to manage high risk.

In a simple term, a deviation means that a problem has occurred and it needs to be addressed. It happens when something does not meet the specification or requirements in some way.

Deviation management solution complements your established nonconformance process and enables your organization by helping to identify the problem, document, evaluate/review, and investigate on need of further corrective actions

Basic Workflow ...

Oasis deviation management software has powerful analytics and reporting capability that provides you a real-time visibility of critical information of the deviations to help you make an informed quality decision.

Non-Compliances Management (OOS / OOT)

Adherence to the specifications and testing for conformity to the written specifications is required for every component of the product such as pharmaceutical ingredients (API), excipients and other components, in-process materials, and finished products/stability samples, if that fails there's an (OOS) out-of-specification test result, an investigation must be conducted and its results documented.

OasisLIMS-QMS offers the flexibility, functionality to record case of OOS and configurable (user defined) investigations checklists with advanced tracking functions. This module helps users capture data on forms automatically from LIMS. The system offers best-practice features to incorporate all the steps and procedures from initiation to summary/conclusion of OOS incident.

The out of trend (OOT) are those suspected results or sequence of results that are within specifications but are unexpected based on historic information such as Assay, RS, Disso., water/LOD etc. Similar to OOS module, there is a separate comprehensive procedure to handle record and investigate out of trend (OOT) results for campus including stability samples.