Regardless of whether you call them deviations, incidents, or out of specification results, the issues that arise in the day-to-day operation of your organization must be dealt with in a way that will meet with regulatory approval. In fact, some deviations are planned when testing a new formula or operating process. In order to properly manage deviations, quality measures must be in place to ensure the root cause of any problem is addressed so that non-conformances will be alleviated and problems prevented.

A deviation management solution must ensure that you follow a consistent, prescribed protocol where you investigate the issue, validate that it is an issue, and proceed with a Corrective Action Plan, just as you would in CAPA management.

QUMAS is an easily configurable system that provides you with a closed-loop process for deviation management and resolution, while integrating with other processes critical to regulatory compliance, such as change control, audit, and customer complaints. This closed-loop approach to compliance automates the generation of internal or external complaints, product non-conformances, deviations, audits, investigations and all other actions. From initiation to closure, QUMAS captures, records, routes, verifies completion and approvals all while auditing each step in the process.

Benefits

QUMAS provides an easily configurable system for deviation management:

• Effectively track and manage deviations; record the root causes
• Improve accuracy with internal incident forms enabling users throughout your company and at any location, department, or site to create, submit and route incidents, complaints, hazards and issues in accordance with your business rules and structure
• Expedite investigations with the ability to create and assign multiple action items to users for executing and supporting the root cause analysis process with due dates, definitions and email notifications
• Utilize practical problem solving techniques including launching a deviation form directly from another form (i.e., CAPA report, customer complaint, etc.). Links are maintained so users can review a completed process and see what triggered the deviation and subsequent CAPA
• Increase accountability by assigning investigations to responsible users and by monitoring due dates
• Benefit from a secure, centralized repository for all documents
• Reduce risk by enforcing consistent and harmonized processes and procedures across the organization
• Proactively avoid repeat errors by improving issue resolution, and by updating related SOPs in real time to avoid recurring mistakes