Risk and vigilance

From the risk register to complaints and vigilance: how MoniDoseQMS follows a product after it reaches the market. Risk management, complaints, adverse events, field safety notices and recalls.

What you'll see

1. 1

   Risk and vigilance: before and after the product reaches the market.

2. 2

   Risk Management: each risk has a score, controls and residual risk.

3. 3

   A risk record shows the initial analysis, the control measures and the result.

4. 4

   Complaints: log customer feedback and decide if it is reportable.

5. 5

   Each complaint is investigated and can be linked to a CAPA.

6. 6

   Adverse Events track incidents and their reporting deadlines.

7. 7

   Field Safety Notices record what you told customers, and who acknowledged it.

8. 8

   Recalls and field corrections are planned and followed to completion.

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