SimplerQMS

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

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Because you already asked about invitations, this prototype demo can add the follow-up: use the role selector before sending each invite to limit access to the teammate responsibilities.

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This prototype demo suggests starting with your workspace profile, inviting the team members who need access, and then connecting the integrations you use.

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In this prototype demo, integrations are configured from workspace settings. Choose the integration, connect the account, and review the enabled permissions.

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In this prototype demo, invite teammates from workspace settings, then choose the access each teammate needs before sending the invitation.

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