A deviation is a shift from an approved instruction and/or process. The Deviation Management allows user to deal with different types of deviations (Planned or Unplanned) including but not limited to product, process, documents, and system.
Intellect’s Deviation Management application enables organizations to establish a GxP to document any modification/shift found or happened during the approved instruction and/or process. The application is designed to classify, categorize and determine the impact of such shift and automatically escalate any unplanned deviation(s) to the nonconformance application to perform thorough investigation(s). The workflow helps to automate and streamline the process for identifying, evaluating, reviewing, handling deviations.
The out-of-the-box Deviation application has console to report meaningful insights, which can be used to better understand and improve business performance. The console landing page is dynamic and reports real time count of Deviation activities created, in progress and closed by the user. The Company metrics includes various charts to report total open and closed deviations by year, deviation type, category and affected department(s).
The process starts with determining and triggering the appropriate Deviation record, Planned or Unplanned. When a new record is created, Intellect automatically assigns unique number for each Deviation record (DEV or UPDEV).
The record initiator then classifies and determines the deviation period to select appropriate start and end dates for the planned deviation. It is then followed by capturing the affected departments, deviation area and category where, the user is provided with various options before routing it for review and approval for the current user’s department head.
The department head either approves or rejects the deviation request and decides if an investigation is required before the deviation is active. If rejected, the record is routed back to the initiator to provide more information.
If approved, record is routed to appropriate affected department(s) head to get buy-in before deviation is active. For unplanned deviation record, by default a deviation is escalated to the nonconformance application so a thorough quality investigation can be performed and followed by closing the deviation record.
For approved planned deviations by affected department(s) head the deviation goes into the active stage where the user can add additional information on the active deviation before it’s routed for a quality verification.
The active deviation period depends on the selection made under create deviation phase. A system sends an email notification to the deviation owner before the end date becomes current. The deviation record is then routed for a quality verification to determine if deviation was effective and an option to create additional nonconformance, if required.
The system automatically generates the a nonconformance record if the deviation is deemed non-effective by quality personnel.
Manual systems leveraging excel or other homegrown solutions are inefficient, prone to human errors, and may delay the resolution to an incident. Intellect’s Deviation Management application automates and streamlines the entire process, from data collection, follow-up, escalation, and resolution of issues.
Users know when and what to do and can review tasks or complete approvals on any device, at any time. At the same time system overcomes bottlenecks, send automated email notifications and reminders that drive accountability and task completion.
Managing Deviation’s with manual processes and paper can be time consuming, disconnected, and costly. Intellect Deviation Management application makes it easy to create a custom form, automate all steps and tasks, and keep the entire process digital.
The solution tracks and streamlines every step and empowers users in the field to complete a task or provide approval using a native mobile application with offline capabilities. Intellect helps to route information to the right person in real-time and shorten the cycle time for resolving an incident.