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From SOC 2 to 21 CFR Part 11: The Compliance Roadmap for Life-Sciences SaaS and AI Companies

Understand what pharma and biotech buyers expect, what your security program already covers, and what to prioritize next.

Join Cycore for a practical walkthrough of the security, quality, and validation requirements that SaaS and AI companies encounter when selling into life sciences. Leave with a clearer path from customer questions to an actionable compliance plan.

Monday, October 12, 2026 · 11:00 a.m. ET

45-minute session + 10–15 minutes of live Q&A
Online · Free registration

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Get access to the live session, replay, and compliance roadmap toolkit.

We’ll email your joining instructions, webinar reminders, replay, and resources.

What can you reuse from your existing security program?

What additional work is needed?

And what should you prioritize before the customer review?

This webinar will help you connect those requests to a practical roadmap for your product and business.

Understand the requirements.

See how SOC 2, ISO 27001, and 21 CFR Part 11 fit into the customer-review process—and where ISO 9001, EUAnnex 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, andrecord 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 pharmaceuticalcustomer’s supplier audit.

Two scientists in white lab coats and gloves examining a test tube with red liquid in a laboratory, smiling as they work together.

You’ll find it relevant if you are:

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.

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 teamsmay 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.

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Questions before you register?

Do we need to have SOC 2 or ISO 27001 already?

No. We’ll cover starting points for companies building their first program, pursuing an assessment orcertification, and preparing for additional customer requirements.

Is this relevant if we don’t have an audit scheduled?

Yes. The session will help you plan ahead and understand the questions that may arise as you pursue lifesciencescustomers.

Can I ask about our situation?

Yes. The session includes live Q&A. Bring a question about your roadmap or a customer requirement, withoutsharing confidential information.

Will I receive the recording?

Yes. All registrants receive the replay and resource pack.