In the FDA and ISO environments, the concept of quality is made tangible by written procedures and specifications, and any deviation from them must be documented and either justified or investigated. Such deviations may occur during sampling and testing, raw material and finished product acceptance, manufacturing and product distribution. The deviation management software system helps in conducting effective investigation and resolution of deviations which are an essential component of quality improvement and compliance.
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The deviation management software system from MasterControl automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement.
Here's how MasterControl addresses some of the major challenges that companies face when resolving deviations.
Deviations Management Challenges
MasterControl Deviations™ Software System
Disconnected Deviations Processes
A paper-based or hybrid system, which consists of disconnected processes, faces a significant challenge in enforcing uniform incident response. The scope of a deviation is usually focused on a single event, rather than a series of events over time. Trends and patterns in occurrence remain hidden, so the quality deviation management system fails to make best use of available data. For example, a paper-based system may overlook repeated occurrences of deviations over a span of 30 days, and consequently fail to alert managers about the need to investigate it, or perhaps launch a corrective/preventive action (CAPA).
The deviation management software from MasterControl is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes. For example, deviation incidents can be correlated to nonconformances, CAPA, or customer complaints. MasterControl leverages the data collected for use in continuous quality improvement.
Poor Tracking of Deviations
It's time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.
Automatic Tracking of Deviations
The system tracks all routing information and data entered into the electronic form, allowing the deviation owner to identify bottlenecks and understand the sequence of events during processing.
For those with paper-based deviation management systems, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process, even if that process involves a small group.
MasterControl's deviation management software system automates data collection, routing, follow-up, and escalation of deviation cases. The electronic in-box tracks all active tasks for a user and provides the tools to stay up-to-date.
The deviation management software from MasterControl is an ideal solution for controlling deviation incidents, for helping avoid their recurrence, and for taking a proactive approach to continuous quality improvement. Below is a summary of its key features.
Replacing a paper-based system with deviation management system and an automated CAPA system, and connecting these with the rest of the quality system (change control, training and other quality software solutions)guarantees quality, compliance, and peace of mind.
Over the long term, an investment in deviation management software and other automated solutions also saves companies a great deal of money in terms of the wasted time that inefficient processes cost companies.
For more information about deviation management software systems, please feel free to contact a MasterControl representative.