From SOC 2 to 21 CFR Part 11: The Compliance Roadmap for Life-Sciences SaaS and AI Companies
Hosted by Cycore
Wednesday, October 21, 2026
11:00 AM–12:00 PM ET
About
Selling AI or SaaS into pharma and biotech? Your SOC 2 report gets you into the conversation, but life-sciences buyers will also ask about quality systems, validation, audit trails, electronic signatures, and whether 21 CFR Part 11 applies to your product.
In this free, practitioner-led webinar, Cycore walks through what pharmaceutical, biotechnology, and clinical research customers expect from their software and AI vendors, how much of your existing security program you can reuse, and how to build an actionable plan for the next 90 days.
What we'll cover:
- How SOC 2, ISO 27001, and 21 CFR Part 11 fit together in a life-sciences customer review
- Which work from your existing security program carries over, and what's new
- Regulated-use considerations: intended use, validation support, audit trails, electronic signatures, and record retention
- Case study: lessons from an AI vendor's pharmaceutical customer audit
- A practical 90-day roadmap for your team
Who should attend:
Software, SaaS, data, and AI companies selling—or preparing to sell—into pharmaceutical, biotechnology, clinical research, laboratory, and other regulated life-sciences organizations. It's especially useful if you:
- Already have SOC 2 or ISO 27001 and need to understand what comes next
- Are deciding whether to pursue SOC 2, ISO 27001, ISO 9001, or another framework
- Have received quality, validation, security, or electronic-record requirements from a life-sciences customer
- Need to determine whether and how 21 CFR Part 11 applies to your product's intended use
In the seat: founders, CEOs, CTOs, COOs, product and engineering leaders, security leaders, and quality or compliance leads.
Speakers:
- Kevin Barona, Founder & CEO, Cycore
- Jai Sisodia, Principal Advisor
Format: 45-minute presentation followed by 10–15 minutes of live Q&A.
Every registrant receives the replay and a resource pack (compliance roadmap, applicability checklist, control crosswalk, sample customer requests, and a 90-day planning worksheet), whether or not you attend live.
Speakers
- Kevin Barona, Founder & CEO, Cycore
- Kevin founded Cycore to bring enterprise-grade security and compliance practices to growing technology companies, helping SaaS, AI, fintech, and health tech teams turn cybersecurity, privacy, and emerging AI risk into a business advantage. Before Cycore, he spent more than 10 years in Big Four consulting at Deloitte, architecting IT and OT/ICS cybersecurity programs for Fortune 500 clients.
- Jai Sisodia, Principal Advisor, Cycore
- Jai brings 15+ years of experience in cybersecurity, enterprise risk management, and IT audit. His background spans fractional CISO services, IT audit leadership at global financial institutions, and CIO consulting. A CISSP, he has published extensively on cybersecurity and emerging technology.
Host
Cycore