Deviation Management Solutions for Life Sciences

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. Your deviation management system must ensure that you follow a consistent, prescribed protocol, where you investigate the issue, validate it as an issue, and proceed with a Corrective Action Plan, just as you would in CAPA management. Your customers and regulatory agencies will also audit your deviation management system, to ensure that all deviations are logged, routed, analysed, and correctly responded to, in accordance with the associated SOP.

The QUMAS Deviation Management Solution will deliver certainty, and also provide insight into trends that can be used to ensure that quality standards are continuously improving over time. Automated forms, business rules and a dynamic workflow engine make up the basis of the best practice QUMAS Deviation Management Solution process, allowing for an action plan to be created and executed to the satisfaction of the initiator. The ability to attach controlled documents and initiate CAPAs during the Root Cause Analysis forms a core part of this holistic QMS, ensuring that business processes are integrated and effectively handled from event capture to closure.

For more information on managing Deviations using the QUMAS solution, download this webinar on QUMAS Quality Management Solution for Global Regulatory Compliance, which outlines how to take control of your quality processes including Deviations, CAPAs, Change Control and Audits. Alternatively, check out this Deviation Process Package from the QUMAS Packaged Solutions, which offers an off-the-shelf approach to Deviation Management.

The QUMAS Solution 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

  • 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