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The Deviation Pro Software Application is a MS Office Add-In that provides a formal interface through which Users can:
- Enter and capture adverse, atypical and deviation events.
- Select from various Root Cause Analysis templates (Five M’s, Failure Mode, Barrier Analysis, Fishbone, etc.) and write-up / perform Root Cause Analysis investigations.
- Link Root Cause Analysis investigations to a specific adverse, atypical or deviation event based on an automatic, unique and reconcilable file numbering and naming convention.
- Sync due dates to your existing MS Outlook Calendar.
- Track and trend adverse, atypical or deviation events based on various tags, types, departments, products, metadata and Root Cause Analysis outcomes.
- Write-up, link and address Corrective and Preventive Action plans (CAPA).
- Generate real-time, ad-hoc metrics, reports, scorecards, charts, etc.
- Track and maintain visibility as items progress from Draft, Review to Approval (with full workflow, email notifications and electronic signature)
- Perform searches for deviation events, root causes and CAPAs using a built-in search engine.
The following screen captures provide a walkthrough of a typical scenario involving the initiation of a deviation event, performance of a root cause analysis investigation and lastly, the assignment of CAPAs. To view a short video demonstration, click here.
From the Main Menu, users can perform various actions such as initiating a deviation, starting a root cause analysis, documenting a CAPA Plan or generating metrics.
Initiation of a new Deviation Event is simple and intuitive. The user selects a deviation type, enters dates of incidence/occurrence, provides brief details of the event, details any impacted products/lots and sets a criticality level.
Only once a deviation event is initiated and approved, can a Root Cause Analysis investigation begin in the system by selecting an analysis type and filling in the Analysis text. The Deviation pro contains built-in templates for various Root Cause Analysis techniques! In this example, an investigator has chosen to use the 5 Whys investigational technique to determine the root cause of the anomaly.
Deviation Pro is designed for ease of use and transparancy. At any time, any user can quickly generate various metrics and scorecards. In this example, a user has quickly generated (in one mouse click) an ad-hoc scorecard for Deviations by Department.
Turnkey pricing is $7500.00 per site/facility with access for multiple users.
For more information on Deviation Pro, click here.
To request more information, ask a question or to schedule a demonstration of Deviation Pro, click here.
To purchase a turnkey build of Deviation Pro, click here.