Qx

Quality

Deviations Management

Streamlined investigation and resolution of product deviations. Improved quality. Simplified compliance. MasterControl deviation management software can help you make it happen.

If your regulated products don’t conform to written specs, you’re required to document why. You also must investigate and justify the reason for the deviation. Compliance is far easier for companies that can conduct these activities quickly and effectively. The MasterControl Deviations™ solution streamlines these efforts. MasterControl deviation management software automates the processes of documenting, investigating, and resolving deviations.

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

01

Optimized Deviations Management

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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.

02

Best-Practice Forms and Processes

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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.

03

Streamlined Compliance

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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.

04

Integrated Processes With Enhanced Reporting

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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.

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Connect Data Across Integrated Processes

MasterControl integrates deviations with other quality processes. It connects data across cross-functional activities. The system centralizes up-to-date deviation data and links it to related concerns like variant management.

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Accelerate Deviation Turnaround Times

MasterControl automates data collection, routing, follow-up and escalation activities. It is designed with compliance in mind. With an advanced deviation system tracking your active deviations tasks, it's easier to stay up to date and resolve issues quickly.

You can't afford sloppy product deviation management.

Continuous quality improvement is achievable with proven deviation software.

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