The Importance of Continuous Compliance Monitoring in Customer and Supplier Qualifications

The Importance of Continuous Compliance Monitoring in Customer and Supplier Qualifications

In the highly regulated pharmaceutical industry, maintaining compliance isn’t just a one-time task—it’s an ongoing process. At Bonafi, we understand the critical role continuous compliance monitoring plays in ensuring the qualification of customers and suppliers.

Key Points:
1.   Regulatory Requirements: As a pharmaceutical company you must adhere to stringent regulations such as GxP and specific regional directives and guidelines. In the EU, the EU Guidelines for Good Distribution Practice (GDP) 2013/C 343/01 is crucial and is based on the Directive 2001/83/EC (Community code relating to medicinal products for human use). In the US, compliance with the FDA’s cGMP Regulations 21 CFR and taking into consideration Good Distribution Practices – Supply Chain Integrity (Chapter 1083) along with the Drug Supply Chain Security Act (DSCSA) is essential.
2.   Risk Mitigation: Continuous compliance monitoring reduces the risk of engaging with non-compliant customers or suppliers, which can lead to costly fines, product recalls, and damage to reputation. Our 365 Scanning function continuously monitors the license data of your qualified customers and suppliers, alerting you to any changes or compliance issues in real time. This proactive approach helps prevent regulatory breaches before they occur.
3.   Qualification and Requalification: Regularly verifying the credentials and compliance status of your partners is crucial. Bonafi’s tools automate the qualification and requalification processes, ensuring that all partners remain compliant over time. This helps maintain a robust and compliant supply chain network.
4.   Efficiency: Automated compliance monitoring saves time and resources, allowing your team to focus on core business activities rather than manual checks. This efficiency is particularly important when dealing with a large number of partners. A significant portion of employees’ time is spent collecting data from various websites and in different formats to support license validation. The Bonafi system efficiently retrieves this data from global register sources, reducing the risk of collecting incorrect information, and allowing your employees to use one application for all their license data retrieval needs.

Conclusion:
Maintaining continuous compliance in the qualification of customers and suppliers is not just about avoiding penalties—it’s about ensuring the delivery of safe and effective products to patients. Bonafi’s advanced compliance monitoring tools provide peace of mind and operational efficiency, helping you stay ahead in a regulated industry.Stay compliant. Stay ahead. Choose Bonafi.

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