SimplerQMS

Events are where your organization records and manages anything that affects quality, from the first time an issue is noticed to a fully resolved and verified outcome. This article introduces…

Events Module Introduction

Understand how a potential quality issue moves from an Observation through to a controlled, approved Quality Event, as well as where CAPAs fit,  so you can route each record to…

Understanding the Events Workflows

Configure who can investigate Observations and how each Quality Event type behaves. Decide on settings such as how the CAPA document type and each CAPA type behave during the Planning…

Settings

Explore everything you need to know about Observations, Quality Events, and CAPAs in SimplerQMS.

Events

Record a potential quality issue as an Observation so it is captured, visible to inbox owners, and routed to the right outcome.

Creating an Observation

Assign reviewers, capture any review input, and decide whether to escalate the Observation to a Quality Event or close it.

Evaluating an Observation

Learn how to create Observations and their escalation or closure.

Observations

In the Assessment stage, author the Quality Event, set access, complete Vigilance Reporting, and decide whether a CAPA is needed.

Assessing a Quality Event

When a Quality Event type has vigilance reporting enabled, capture reportability and its rationale before the record can move from Assessment to Review or Approval.

Vigilance Reporting

Move the Quality Event through review: the Author sends it for review, Reviewers complete their review, and the Author finalizes the draft before approval.

Reviewing a Quality Event

Approve the Quality Event with an electronic signature. Once every required approval is captured, the record closes and an effective PDF is released.

Approving a Quality Event

Reopen a closed Quality Event when an update is needed or archive a Quality Event that is no longer required.

Reopening a Quality Event

The intended workflow expects a linked CAPA to be closed first. When that isn't possible, the Quality Event Owner can progress the record using a documented exception.

Closing a Quality Event without CAPA closure

Quality Events

Create a CAPA from a Quality Event during its assessment, or as a standalone document, and start it in the Draft state of the Planning phase.

Creating a CAPA

In the Planning phase the CAPA is drafted, authored, and its corrective and preventive actions are defined, then sent for review or approval.

CAPA Planning

When Planning approval is complete, the CAPA moves to In Execution and the corrective and preventive actions are carried out and completed.

CAPA Execution

A review applies in the Planning and Execution phases when the CAPA type requires it. The reviewer checks the content and marks the review complete.

Reviewing the CAPA

An approval applies in the Planning and Execution phases when the CAPA type requires it, and is captured with an electronic signature.

Approving the CAPA

Learn how to assess the effectiveness of the CAPA after the due period is passed.

Assessing the Effectiveness of the CAPA

When the effectiveness check concludes the CAPA was not effective, the system reopens it as a new version so further actions can be planned and executed.

Reopening the CAPA if not effective

Learn how to create CAPAs and how corrective and preventive actions are managed from initiation to closure.

CAPAs

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