From SOC 2 to 21 CFR Part 11: The Compliance Roadmap for Life-Sciences SaaS and AI Companies
Online · Free registration
Save your spot.
We start in
Your next customer may ask for more than SOC 2
What can you reuse from your existing security program?
What additional work is needed?
And what should you prioritize before the customer review?
Leave with a clearer next step
Understand the requirements.
See how SOC 2, ISO 27001, and 21 CFR Part 11 fit into the customer-review process—and where ISO 9001, EU Annex 11, GAMP 5, and ISO 42001 enter the conversation.
Reuse the work you’ve already done.
Learn which controls and evidence may support additional customer requirements, which need strengthening, and where you may need new processes or product capabilities.
Understand what regulated use adds.
Explore the questions surrounding intended use, validation support, audit trails, electronic signatures, and record retention—including how vendor and customer responsibilities differ.
Prioritize your next 90 days.
Identify a starting point based on your current compliance program, product, and customer requirements. We’ll bring the discussion to life through an anonymized AI software vendor’s experience with a pharmaceutical customer’s supplier audit.
Built for SaaS and AI companies selling into life sciences
- Entering the life-sciences market and deciding where to start.
- Pursuing SOC 2 or ISO 27001 and planning your next steps.
- Already operating a security program and receiving additional quality or validation requests.
- Preparing for a customer’s supplier review or audit.
Trusted by Technology Companies Navigating Compliance
"What I valued most working with Kevin was that he never operated like a vendor. From the first engagement, he and his team behaved as an embedded partner, sitting inside our processes, owning the work alongside us, and treating our certification as their own deliverables."
"Jai's clear communication and detailed readiness assessment for SOC2 ensured that we had a clear compliance roadmap. Their professional conduct and thorough understanding of SOC2 principles have not only prepared us for the audit but also instilled greater confidence in our team regarding security measures."
"Being in the healthcare space, we take security and privacy seriously. Cycore's services allowed us to have the security expertise at hand when it mattered the most."
Your registration includes a practical resource pack
Compliance roadmap:
See how the different frameworks and requirements relate.
Applicability planning checklist:
Identify questions to explore about your product’s intended use and electronic records.
Control crosswalk:
Map existing security controls to areas requiring additional evidence.
Representative customer request list:
Understand the documentation pharmaceutical quality teams may ask for.
90-day planning worksheet:
Organize priorities around your company’s starting point.
Webinar replay:
Revisit the session or share it with your team.
Every registrant receives the replay and resources, whether or not they attend live. No additional form required.