Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requirements, code development/management practices, version control, change control, compliance with 21 CFR Part 11 (electronic records/electronic signatures), testing, operations management, disaster recovery, document management, and customer service. A template and checklist are provided for use in conducting vendor audits. These will help guide you through the process and ensure you fully assess the vendor’s capability.

Effective and compliant computer system development, testing, and validation are critical to any pharmaceutical or FDA-regulated organization. You should attend this seminar if you are responsible for planning, executing, or managing a computer system that is governed by FDA regulations. A full understanding of how to assess the vendor’s practices is essential to ensuring compliance and is a first step in the validation of a computer system regulated by the FDA.

• Developing a strategic approach to vendor audit
• Understanding best industry audit practices to ensure FDA compliance
• Identifying the key areas of vendor performance that are necessary to ensure they will meet your compliance requirements
• Knowing the right questions to ask about an array of key areas that could have an impact on security and validation
• Understanding how to investigate 21 CFR Part 11 (electronic records/electronic signatures) compliance
• Understanding how a vendor will provide the customer service and support required to run your critical business operations
• Identifying the procedural controls needed to support areas where there may be technical control gaps or weaknesses
• Determining how to monitor the vendor over time, performing audits through questionnaires or on-site visits
• Understanding ways to leverage your vendor’s experience and expertise to assist with Installation Qualification and Operational Qualification
• Understand how to assess a vendor’s ability to provide custom code, testing assistance, and training to your team
• Learn how to carefully document all activities related to your vendor to ensure compliance

Auditing vendors of computer systems regulated by the FDA is crucial to ensure compliance with regulatory standards, such as 21 CFR Part 11, which governs electronic records and signatures. Implementing best practices in these audits helps identify potential risks, verify system integrity, and ensure data security and accuracy. Proper auditing also minimizes the risk of non-compliance, avoids costly penalties, and ensures that the vendor’s systems meet FDA requirements for validation, traceability, and accountability, ultimately safeguarding product quality and patient safety.

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