Nonconformance management software systems can make nonconformance management more efficient and compliance with FDA regulations and ISO standards easier. There are several references to the importance of material and product conformance to accepted specifications in the FDA's Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. For example, it requires testing of components for conformity with all appropriate written specifications for purity, strength, and quality. CGMP also requires that laboratory controls include the establishment of appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, materials, and drug products conform to appropriate standards of identity, strength, quality, and purity. ( 21 CFR Part 211.84 )
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MasterControl nonconformance management software is a configurable and easy-to-use solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. Here are some of the common challenges for high-tech manufacturing companies pertaining to nonconformance and how MasterControl addresses them. See why MasterControl Nonconformance helps ensure your system is Compliant, Connected, and Complete.
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.
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.