Deviation Software Systems

Deviation Software Systems Help Ensure Compliance with FDA CGMP and ISO 13485

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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How can MasterControl Deviation Software Systems Benefit You?

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.

Continuous Validation for FDA CGMP Compliance with Deviation Software

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 ChallengesMasterControl 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).

Connected Processes

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.

Faster Turnaround

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 Deviations™ The Ultimate Deviation Software for Managing Planned Deviations and Unplanned Deviations

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.

  • Best-Practice Form and Process : A pre-configured, multi-page form prompts participants to collect and track all relevant data and guides them through the process while allowing responsible personnel to make the appropriate decisions. The form in deviation software is automatically routed to the appropriate personnel and can escalate if not processed in a timely manner.
  • Four-Step Process with Electronic Approval Signatures: This best-practice workflow will guide users through the entire process of resolving a deviation incident, beginning with initiation through investigation, resolution, and approval.
  • Integrated with CAPA Process: MasterControl Deviations can be integrated with MasterControl CAPA, so serious cases can immediately move on to the process of corrective/preventive action investigation and resolution.
  • Integrated with Nonconformance Process: When integrated with MasterControl Nonconformance module in deviation software, any deviation that results in a material nonconformance will automatically move to the nonconformance disposition process.
  • Integrated with Electronic Batch Records Process: MasterControl deviation system connects with MasterControl Electronic Batch Records to create a complete automated solution for manufacturing operations.
  • Form-to-Form Launching: A CAPA form or a nonconformance form can be launched directly from the deviation form. By the same token, a deviation form can be launched from a control recipe form in the MasterControl Electronic Batch Records solution. MasterControl's deviation software also maintains the links so a completed process can easily be reviewed to see what triggered it. Relevant information from the deviation form is automatically transferred to the launched form, reducing data entry and increasing accuracy.
  • Analytics Reporting Tool: This built-in tool associated with deviation software comes with a standard set of pre-configured reports that can be adjusted and customized by the end user. Planned deviations and unplanned deviations can be trended and analyzed by process, product, vendor, etc. These data-mining capabilities of the reporting tool provides important insight into systemic quality issues and serve as yet another starting point for CAPA.
  • FDA 21 CFR Part 11 Compliant System: As with all software developed by MasterControl, this electronic deviation system is fully compliant with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval, and password expiration, encryption, and certification.

For More Information about Deviation Software Systems

For more information about the deviation software systems from MasterControl, please feel free to contact a MasterControl representative.