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Document control and quality events

Controlled documents with approvals, plus the quality events that keep a QMS alive: changes, deviations, non-conformances and CAPA.

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Controlled documents with approvals, plus the quality events that keep a QMS alive: changes, deviations, non-conformances and CAPA. Documents, change control, deviations, non-conformances and CAPA.

What you'll see

  1. 1

    Document control and quality events live together in one menu group.

  2. 2

    Document Management holds your controlled documents: SOPs, work instructions, forms.

  3. 3

    Start faster with the SOP template library: ready-made drafts by topic.

  4. 4

    Change Control: every change is assessed, approved and implemented in steps.

  5. 5

    A change record shows its impact assessment, approvals and linked records.

  6. 6

    Deviations record what did not go as planned.

  7. 7

    Non-conformances capture product or process issues and their disposition.

  8. 8

    CAPA: investigate the root cause, act, and verify the fix worked.

  9. 9

    Inside a CAPA: root cause, actions, effectiveness check, files and signatures.

  10. 10

    Quality KPIs and cost of quality show how the system is performing.

The screens show sample data for a fictional company, Nordic MedTech Oy. Captions are on screen and available as a CC track.

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