Know what your pharma customer will ask for, before they ask.
Your SOC 2 answered the security section. The rest of the questionnaire is about quality.
Most of that falls outside a security audit. And there is no Part 11 certificate to buy your way out of it. FDA doesn't certify systems, so your customer will judge the evidence you give them.
SOC 2 covers the platform,
not the record.
It answers "did your controls work?" Your customer needs to know whether they can trust a regulated record.
Part 11 follows the record.
Whether it applies depends on what each feature does, not on your company as a whole.
Your access can become their finding.
When a vendor mishandles regulated data, the warning letter often goes to
the customer, and the customer remembers.
Five deliverables your team can act on, and your customer can read.
Feature scoping memo
Every feature checked against the four Part 11 triggers. For features in scope, you'll know which records and signatures need controls. For features out of scope, you get the documented reasoning, ready for the day a customer asks.
Part 11 gap rating
Your program rated against all 27 Part 11 sub-provisions and mapped to the SOC 2 or ISO 27001 controls you already run. Each one is marked Reuse, Extend or Build, so you see what carries over and what's new.
Customer-ready positioning
Language you can safely use with buyers ("Part 11-capable," not "Part 11 compliant"), plus a review of your trust center and sales materials for claims that create risk.
Sequenced 90-day plan
What to do first, second and third, based on your product, your customers and your engineering capacity. It ends with clear criteria for your first readiness gate.
Readout session
A working session with your team to walk through the findings, plus a summary version you can share with a customer who's asking where you stand.
Three weeks. About three hours of your team's time.
Scoping call (30 minutes)
Tell us about your product, your customers and what they're asking for. We'll confirm the assessment is a fit before you commit to anything.
Scope
We review your features, data flows and any customer questionnaires, then check each feature against the four triggers.
Assess
We rate your current program against the 27 sub-provisions and map what your existing controls already cover.
Plan and read out
You get the scoping memo, gap rating, positioning guidance and 90-day plan, walked through live with your team.
Three weeks. About three hours of your team's time.
Questionnaire triage
Send us the supplier questionnaire your customer sent you, or the one you expect. We'll mark up which answers your SOC 2 already supports and which need Part 11 or quality evidence.
Full fee credit
If you go on to work with Cycore on implementation, the assessment fee is credited toward that work.
Fixed fee
One price, agreed up front. No hourly billing and no open-ended scope.
Built for SaaS and AI companies selling into life sciences.
This is a good fit if you:
- Sell software to pharma, biotech, clinical research or lab organizations
- Have SOC 2 or ISO 27001, or are working toward one, and are now getting quality or validation questions
- Received a supplier questionnaire, audit request or quality agreement and aren't sure what applies
- Ship AI features that draft, flag or touch records your customers rely on
- Want to stop saying "Part 11 compliant" and start saying something you can back up
This isn't the right fit if:
- Your product is regulated as a medical device itself. That's a separate FDA path.
- You need a legal or regulatory opinion. This is a practical readiness assessment, not legal advice.
Trusted by Technology Companies Navigating Compliance
"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."
"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."
"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 Advisors
Questions before you book?
Do we need SOC 2 or ISO 27001 already?
Is this an audit?
What do you need from us?
Can we share a customer's questionnaire with you?
What if Part 11 doesn't apply to us?
Does this cover our AI features?
What happens after the assessment?
I watched the replay instead of attending live. Does this still apply?
Walk into your next supplier review with a plan.
Book a 30-minute scoping call. We'll talk through your product and what your customers are asking for, and you'll know whether the assessment is a fit before you commit.
General information, not legal or regulatory advice. FDA does not certify electronic systems; Part 11 compliance is determined by the regulated company.