Quality Events Management | Unplanned Deviations

Quality Events is an application used to track & trend or manage the investigation process of a variety of unplanned events or deviations that impacts the quality, performance, safety, or reliability of a product or against cGMP.

• The app provides a standard process for investigating an event to ensure each investigation is performed consistently and in a timely manner.
• Organizations can discover trends that might not have otherwise been obvious. Quality Events is a central component to systematically detecting and correcting issues.

Organizations can manage a broad set of unexpected or unplanned deviations, providing a single source of entry – one place to capture all different types of events. Manual deviation systems are time-consuming,  prone to delays, wrought with inconsistent processes and challenging to monitor progress.

• ETQ Reliance has the broadest set of deviation management applications that include  Customer Complaints, Customer Feedback, Lab Investigation, Planned Deviations , NCM and CAPAs.
• In addition to the standard workflows, Quality Events has optional sections to integrate with other Reliance applications as appropriate, such as Audits, Document Control, and Supply Chain Management.
• Ensure products meet 21 CFR part 11 and EU Annex 11 quality standards

Collect, track, trend, and resolve a broad range of unplanned deviations. You can choose from a library of predefined quality events or create your own custom events. Manage deviations related to audit findings, complaints, non-conformances, out-of-spec, out of trend, procedures, regulations, and more.