Nonconformance Management Software Features & Benefits

Software System Integrates Nonconformance and CAPA Processes to Ensure Compliance with FDA Regulations and ISO Quality Standards

In stringent FDA and ISO environments, a nonconforming product, material, or component could lead to costly rework and scrapping, or worse, a product recall. A product's quality, reliability, and safety depend to a great extent on its conformance to specifications and parameters that have been tested, proven safe, and approved. FDA's Current Good Manufacturing Practice (CGMP) regulations 21 CFR Part 211, 21 CFR Part 820 and the most popular ISO standards (ISO 9001, ISO 13485, ISO 14001) all require proper disposition of nonconformances.

How Can MasterControl Nonconformance™ Software System Benefit You?

MasterControl Nonconformance™ is a configurable and easy-to-use software system designed to automate, manage, and streamline paper-based processes for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. Here's how it can answer key challenges faced by companies in handling nonconformances. See why MasterControl Nonconformance helps ensure your system is Compliant, Connected, and Complete.

Nonconformance Challenges		MasterControl Nonconformance™ 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 process 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 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 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 system makes it almost impossible to identify and avoid bottlenecks.		Automatic Nonconformance Tracking The 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.