eQMS Planned Deviation Module

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eQMS Planned Deviation Module

A compliance-driven module to ensure deviations remain under control
The eQMS Planned Deviation Module is a compliance-driven tool that enables you to keep deviations under control and in accordance with your internal procedures and regulatory standards. The module is based on processes supporting deviation management, ensuring audit trail, and streamlining risk assessments.
Manage planned deviations of documented processes or procedures
This module will manage your planned deviations for complex or non-standard processes and procedures. It allows you to document, manage and control your process deviation requests from initial planning through the detailed approval process.

Manage customer reporting and approval processes

eQMS Planned Deviation Module is designed to manage customer reporting and approval processes. Create pre-set reports in the system and start approval processes with clear notifications that assist users in tracking and managing customer response. This module helps you eliminate paper waste as well as keep your customers satisfied by responding to their requests on time.

Monitor active deviations and get notifications on status changes

This module helps you stay on top of your active deviations and ensure that they’re getting the attention they need. Monitor active deviations and get notifications when their statuses are about to change. When a deviation is about to expire, the identified user(s) are notified to either close out the deviation or apply for an extension.
Risk assessment on all planned deviations
The module helps you to assess and manage the risk associated with deviation planning, including identifying and communicating identified risks to stakeholders. It simplifies deviation processing by linking information about planned deviations with risk assessments and providing a single source of truth for all stakeholders involved in deviation processing and approval.
Full traceability of deviation process and reasons
The planned deviation module allows you to manage deviations for multiple processes in a single solution. Increase productivity and ensure compliance with regulatory requirements by streamlining your quality data flow and generating accurate reports reflecting the reasons for the deviation and its progress.

Identify reoccurring deviations and plan for permanent changes

Make adjustments to reduce recurring situations, limit the number of duplicate deviations, decrease the impact of deviations on manufacturing and quality, and improve your overall processes.

Keep track of schedule, product, or procedure deviations

Analyzing the trend of causes for each deviation and analyzing the group of affected deviation areas supports an efficient deviation management system. By using automated data collection and analysis, you can reduce the time needed to find recurring issues in your processes.
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