Deviation Management
A key component in any quality system is handling nonconformities and/or deviations. Deviations originate from numerous sources including complaints, product rejections, non-conformances, recalls, deviations, audits and regulatory inspections and findings.
A key component in any quality system is handling nonconformities and/or deviations. Deviations originate from numerous sources including complaints, product rejections, non-conformances, recalls, deviations, audits and regulatory inspections and findings. Health authorities require documentation for the investigation, conclusion, and follow-up of each deviation.
NextDocs Deviation Management Software
Effective deviation management from draft, to review, to approval, to closure.
The NextDocs Deviation software manages Deviations and Out of Specifications (OOS) from creation through investigation and then on to approval and closure. Furthermore it allows for the automatic creation of CAPAs if necessary to address the deviation. With fully configurable forms and workflows, the NextDocs Deviation Management Software provides powerful and easy to use capabilities to resolve deviations efficiently as part of an effective quality management program.
NextDocs Deviation Management Software offers the following benefits and features:
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Features
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Benefits
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Extensively configurable electronic forms with role-based sections
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Allows automation of client-defined processes and steps without customization.
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Sections locked down upon completion and subject to only compliant modifications
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Improves data integrity as users cannot change data accidentally; focuses each task on the specific actions and data required for completion.
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Dynamic routing of workflow based upon data entered
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Automates the execution of defined processes, for example, including or excluding safety or regulatory input based on the nature of the deviation; eliminates unnecessary steps.
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Automatic assignment of tasks to predefined users, groups or roles when applicable
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Ensures that tasks are handled by the appropriate users; eliminates manual tasks.
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Automated notifications and escalations of CAPAs to the correct responsible parties
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Provides participants with insight into assigned tasks and their statuses even when they are not logged into the system; highlights upcoming and overdue tasks.
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Data-driven approach allowing capture of key information for reporting and trending
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Insight into root cause, state of control and process efficiencies.
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21 CFR Part 11 compliant electronic signature
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Allows efficient use of the system across physical locations and eliminates costs associated with printing, couriering and storing paper documents.
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Detailed audit trail
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Provides Part 11 compliance as well as insight into activities completed in the handling and closing of a deviation.
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Automated process forwards tasks to designated recipients upon completion of previous tasks
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Increases efficiency by decreasing the manual intervention needed to process a deviation.
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Closed loop process
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Allows automated closure (such as closure of an associated deviation upon closure of a CAPA) if all information is available to justify closure; if not, notifies responsible user to complete the closure process when appropriate. Reduces the risk of dropped handoffs and the associated compliance impact.
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Efficient handling of supporting documentation such as photographs, emails, etc.
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Allows access to supporting materials to support decision-making and investigation without controlled document processing unless appropriate.
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