Nonconformance Management Software Systems

Nonconformance Management Software Systems Integrates Nonconformance, CAPA, and other Quality Processes to Ensure Compliance with FDA Regulations and ISO Quality Standards

Regulated environments require that materials and products conform to certain specifications. When they don’t, nonconformance management software is used to detect, evaluate, review and handle those issues.

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Regulated Companies Need Nonconformance Software

Any company that operates within a regulated environment and/or is ISO certified needs a standardized process for dealing with nonconformances. Sooner or later a company will encounter a nonconforming product, material or component, and when it does, resolution is faster and simpler when using nonconformance software.

Nonconformance Management Software Challenges

MasterControl Nonconformance Management Software

Disconnected Nonconformance Processes

In manual or hybrid systems, the reporting of and response to a nonconformance are likely to be disconnected, which could result in delayed resolution. A nonconformance management system that's not connected to the corrective/preventive action (CAPA) system could pose serious problems in terms of the timeliness and accuracy of data collection and the thoroughness of documentation, all of which are critical to compliance.

Connected Nonconformances

MasterControl's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. MasterControl's nonconformance management software offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it.

Poor Nonconformance Turnaround

A manual system is inherently inefficient. Paperwork may languish in someone's desk, and for a sequential process such as nonconformance, it could mean a delay in resolution of the incident.

Fast Nonconformance Turnaround

MasterControl's nonconformance management software automates data collection, routing, follow-up, and escalation of nonconformance cases. The electronic "in" box tracks all active tasks for a user and provides tools for staying on top of things. Approvers can also review and sign electronically. All of these things help shorten cycle time.

Poor Nonconformance Tracking

It is time-consuming to physically track paperwork. A manual nonconformance management system makes it almost impossible to identify and avoid bottlenecks.

Automatic Nonconformance Tracking

The nonconformance management software system tracks all routing information and data entered into the electronic form, allowing the nonconformance owner to identify bottlenecks and understand the sequence of events during processing.