It is not unknown that when a service, product, or process fails to fulfill predefined specifications or industry regulations and standards, it is referred to as a non-conformance. And, it has a negative influence on the cost, reputation, efficiency, and effectiveness of businesses. Thus, Non-conformance management software is a valuable quality tool since it is a critical Quality Management System (QMS) performance indicator that may quickly detect issues inside a company. In simple terms, non-conformance management is the process of identifying, documenting, evaluating/investigating, segregating and disposing of non-conformances in accordance with the applicable regulations and standards- something really difficult without an automated system.
Designed to meet or exceed customers’ expectations, the Non-Conformance module of BatchMaster QMS lets you log an issue, upload any evidence, classify the type, associate severity, and assign it to the appropriate authority for management.
It automates manual record-keeping and provides detailed statistical analysis by controlling the life cycle of nonconformance events, as well as cost tracking and user responsibility assignment at each stage. By detailing all of the differences that must be documented in relation to a product, process, or procedure, the Non-conformance Report aids in meeting FDA regulations.