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

On May 30, 2024, Amorit Education hosted a critical and enlightening webinar entitled "Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA". Featuring Carolyn Troiano, a seasoned expert with over 40 years of experience in computer system validation, the session offered a deep dive into the stringent requirements of FDA compliance and the best practices for auditing vendors.

1) Unpacking the Essentials of FDA Compliance:

Carolyn opened the session with a powerful overview of the regulatory environment, stressing the non-negotiable nature of thorough documentation. "In the realm of FDA compliance, the absence of documentation equates to the absence of the action itself," Carolyn stated, setting the tone for the importance of precision in regulatory practices.

2) Deep Dive into Vendor Audits:

A significant portion of the webinar was dedicated to understanding vendor audits—a critical checkpoint for any FDA-regulated company. Carolyn provided a granular breakdown of audit procedures, criteria, and best practices. "When auditing a vendor, it's imperative to scrutinize every aspect from system security to data integrity controls. These components are foundational to safeguarding the quality and compliance of computer systems," she explained.

During the session, Carolyn walked the attendees through various scenarios and case studies, illustrating the potential pitfalls and how to address them proactively. She emphasized the importance of a proactive approach, "Vendor audits aren't just a formality; they are a crucial firewall against compliance risks."

3) Validation Processes: Ensuring Reliability and Compliance:

The conversation then shifted to the critical processes of system validation. Carolyn meticulously explained the differences between Computer System Validation (CSV) and Computer Software Assurance (CSA). "While CSV has traditionally focused on exhaustive documentation to demonstrate compliance, CSA advocates for a risk-based approach, emphasizing critical thinking and efficiency," she remarked.

Carolyn stressed that transitioning to CSA could significantly enhance operational agility without compromising on compliance. "Adopting CSA means placing trust in risk-based assessments rather than blanket checks. This not only streamlines processes but also allocates resources more effectively," she added.

4) The Pillar of Data Integrity:

Data integrity was highlighted as a cornerstone of FDA compliance, with Carolyn explaining its critical role in ensuring the reliability and accuracy of data that guides decision-making in regulated environments. "To uphold data integrity, every piece of data must be attributable, legible, contemporaneously recorded, original or a true copy, and accurate," she detailed. Carolyn further elaborated on the implications of data integrity breaches and shared best practices for maintaining stringent controls.

5) Practical Takeaways and Strategies:

Carolyn concluded the webinar with strategic insights into implementing robust compliance frameworks. She offered actionable advice tailored for IT and compliance professionals in FDA-regulated industries. "Implementing layered security measures, conducting regular audits, and fostering a culture of compliance are pivotal," she advised.

The session ended with a dynamic Q&A, where Carolyn addressed specific concerns from the audience, providing tailored guidance that participants could apply to their operations.

Exclusive Sneak Peek: A 10-Minute Excerpt from Our Webinar:

To give you a taste of the invaluable insights shared during our webinar, we are excited to offer a 10-minute excerpt from "Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA." This segment features Carolyn Triano delving into some of the most critical aspects of vendor audits and system validation processes.

Full Webinar Available for Purchase:

If the topics discussed in the excerpt resonate with your professional needs, consider purchasing the full 100-minute webinar available on our platform -

PURCHASE HERE.

The complete session includes detailed explorations of all aspects of FDA compliance, from documentation essentials to the nuances of data integrity and the latest in regulatory frameworks.

By accessing the entire webinar, you will gain:

• Comprehensive guidance on navigating FDA regulations
• In-depth understanding of audit best practices
• Strategies for implementing Computer Software Assurance effectively
• Insights into maintaining impeccable data integrity standards
• Real-world applications and case study analyses

This webinar is an essential resource for IT and compliance professionals in the pharmaceutical, medical device, and other FDA-regulated industries looking to stay ahead in a dynamic regulatory environment.

Join us in advancing your knowledge and ensuring that your practices not only meet but exceed the expectations of FDA regulatory standards.