Deviation Management Software

Streamlining Deviation Management for Improved Product Quality and Compliance

MasterControl's deviation management software provides a streamlined solution for the investigation and resolution of product deviations, resulting in improved quality and simplified regulatory compliance. When regulated products fail to meet written specifications, it is crucial to document the reasons behind the deviation and conduct a thorough investigation.

MasterControl's Deviations™ solution enables companies to efficiently document, investigate, and resolve deviations, ensuring compliance with regulatory requirements. Maintaining product quality is paramount in regulated industries, and deviations from approved processes, procedures, instructions, specifications, or established standards can compromise this quality. By utilizing MasterControl's deviation management software, companies can expedite the identification and resolution of deviations, facilitating prompt corrective actions and minimizing the impact on product quality.

The MasterControl Deviations™ solution automates the deviation management processes, eliminating manual paperwork and reducing the time and effort required to document, investigate, and resolve deviations. This software provides a centralized platform for capturing and analyzing deviation data, enabling efficient collaboration and ensuring comprehensive compliance.

Deviation management is crucial for organizations operating in regulated environments, as it helps maintain product quality and aligns with the guidelines set forth by regulatory authorities such as the EU GMP and the U.S. FDA. With MasterControl's deviation management software, companies can effectively address deviations, strengthen their quality management processes, and streamline compliance efforts.

The ideal solution for controlling and avoiding the recurrence of deviations.

• Optimized Deviations Management
• Best-Practice Forms and Processes
• Streamlined Regulatory Compliance
• Integrated Quality Processes With Enhanced Reporting

Peace of mind. It’s what you get when you can effectively control and proactively mitigate quality risks. And with a proven track record of helping manufacturers achieve deviations management success, that's what MasterControl provides. MasterControl helps you make deviation control a tool for continuous quality improvement.

MasterControl's built-in preconfigured forms guide users through the process of collecting deviations information. The multi-page forms prompt users to capture and track all pertinent data and make suitable decisions. The system automatically routes completed forms to the appropriate decision-makers. If a form is not handled in a timely manner, the system can be set to escalate the issue.

MasterControl deviations management systems are designed with quality compliance in mind. By providing secure, time-stamped audit trails, full reporting and electronic signature capabilities, MasterControl facilitates compliance with regulations like 21 CFR Part 11 and 21 CFR Part 820. The system even exceeds the good business practice requirements of standards such as ISO 9000 and ISO 13485.

MasterControl can automatically transfer information into forms for other quality processes (such as nonconformances) and launch those forms directly from a deviation, which greatly reduces data entry errors. Plus, the system lets users analyze and trend deviations by process, product, vendor or other inputs. The insights drawn from these analytics help reveal systemic quality issues.

Learn More About MasterControl's Deviation Management Software

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MasterControl Deviation Software Reviews

Robust and Well-Designed QMS System for Deviations

"MasterControl's QMS system is easy to learn and configure. The flexibility for document workflows and processes makes implementation an easy task. Other systems will require customization and additional assistance to configure the tool.

MasterControl Quality Excellence allows users to review, collaborate and approve documents safely and electronically. It provides an interface for teams to work on a process and track information for any quality event.

"Jennifer R.