Incident Monitor: Pharma Regulatory Non Compliance Trending and Alerting
Anticipate supply chain interruption with the Incident Monitor
Non-compliance issues are often the biggest threat to the smooth running of pharmaceutical supply chains. A single enforcement action can cause irreparable damage to profit margins and reputations.
But what if you could build up a picture of the non-compliance activity in your supply chain and anticipate interruption issues before they occur?
The Regulatory Incident Monitor collates non-compliance and supply chain interruption information from previous recall warning letters, product shortages, import alerts and GMP non-compliance reports from leading medicines regulators such as the FDA and EMA.
SCAIR® then uses this information to build a history of your supply base’s quality performance. You’ll be able to identify repeat offenders by company name.
SCAIR® goes further by providing root cause analysis and trending across different sectors; drugs, biologics, veterinary and medical devices. It also analyses different product characteristics (therapeutic area, dosage form and route of administration) to determine which product types are most likely to trigger non-compliances.
You can then use such a detailed non-compliance history to take the necessary steps towards mitigation to protect your supply chain.
For more information on how SCAIR® can help you monitor regulatory compliance data, take a look at our non-compliance consolidator tool.