MasterControl Deviations Software facilitates compliance with FDA's QSR and 21 CFR Part 11 requirements, as well as ISO 13485 quality management standards.
CGMP requirements for medical devices found in 21 CFR Part 820, also known as Quality System Regulation or QSR, are some of the toughest in the manufacturing industry. From the initial design of a medical device through the production process, the FDA requires manufacturers to conform to specifications that help ensure product safety and quality. MasterControl provides deviation systems for the manufacturing companies to ensure compliance with the FDA regulations.
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MasterControl deviation software systems consist of deviations software for managing deviations, including the process of documenting, investigating, and resolving deviations from written procedures. This deviation software provides the capability of resolving a deviation efficiently and of using data collected as a basis for continuous quality improvement.
MasterControl considers validation an integral part of software solutions for FDA-regulated customers. Our 'continuous validation' approach dramatically cuts the time, pain, and cost involved in validation, making it easier to validate future upgrades. MasterControl's deviation software is a continuum of products and services address different levels of validation needs based on individual risk assessment.
Here's how MasterControl's deviation software addresses some of the major challenges that companies face when resolving planned deviations and unplanned deviations.
|Deviations Management Challenges||MasterControl Deviations™ Software System|
|Disconnected Deviations Processes
A paper-based or hybrid deviation 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 system fails to make best use of available data. For example, a paper-based system may overlook repeated occurrences of deviations from release specifications or material specifications 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 deviations software from MasterControl is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes, including CAPA, OOS, and electronic batch record management. For example, deviation incidents can be correlated to nonconformances and customer complaints. MasterControl leverages the data collected for use in continuous quality improvement required by the FDA.
|Poor Tracking of Deviations
It's time-consuming to physically track paperwork. A manual deviation system makes it almost impossible to identify and avoid bottlenecks.
|Automatic Tracking of Deviations
Deviations software 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.
| Poor Turnaround
For those with paper-based systems, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process, even if that deviation system involves a small group.
The deviation software from MasterControl 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.
MasterControl's deviation system is an ideal solution for controlling deviation incidents, for helping avoid their recurrence, for taking a proactive approach to continuous quality improvement, and for ensuring FDA and GxP compliance. Below is a summary of its key features.
For more information about the deviation software systems from MasterControl, please feel free to contact a MasterControl representative.