Question 1

What is the main focus of this webinar?

Accepted Answer

This webinar focuses on FDA expectations and updated requirements for software verification and validation (V&V) used in medical device and drug manufacturing, including production/test equipment, quality systems, cloud-based solutions, and cybersecurity aspects.

Question 2

Why is software validation important for FDA-regulated companies?

Accepted Answer

Software used in production, quality systems, and data management can significantly impact product quality, regulatory compliance, and patient safety. Validation ensures the software performs as intended and meets FDA expectations for documentation and risk control.

Question 3

Does the webinar cover 21 CFR Part 11 requirements?

Accepted Answer

Yes — there is an overview of 21 CFR Part 11 (electronic records and signatures) and how Part 11 relates to software V&V documentation and compliance activities.

Question 4

Will cybersecurity issues be discussed?

Accepted Answer

Yes — the webinar addresses the role of cybersecurity in software validation, an increasingly critical concern as software systems grow more connected and cloud-based.

Question 5

What types of software are covered in this session?

Accepted Answer

The webinar discusses V&V for:

Production/test equipment software

Quality Management System (QMS) related software

Cloud and networked systems

Legacy, hybrid, and new software applications

Question 6

Is there a risk-based approach to FDA software validation?

Accepted Answer

Yes — the FDA continues to encourage a risk-based validation strategy where validation effort and documentation intensity are scaled to the potential impact on product quality and patient safety.

Question 7

Will this webinar help me prepare for FDA inspections?

Accepted Answer

Attendees will gain actionable insights into expected documentation deliverables, common validation failings, and fixes — all of which are useful when preparing for audits and inspections.

Question 8

Will practical templates or models be shared?

Accepted Answer

Yes — the webinar includes examples of an FDA-recommended model and documentation templates to help attendees develop repeatable V&V frameworks.

Question 9

Do I need prior software validation experience to benefit from this webinar?

Accepted Answer

While helpful for beginners, the webinar is especially valuable for those with some foundational knowledge of software validation who need to understand FDA’s current stance, documentation expectations, and risk-based approaches.

FDA's New Software Validation Requirements

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FDA's New Software Validation Requirements

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