Kintavo Achieves SOC 2 Type II Compliance
Kintavo has completed its SOC 2 Type II examination. For the quality and regulatory teams who trust Kintavo with the records that define how their products are made, tested, and controlled, this is more than a badge. It is independent, third-party assurance that the platform protecting your most sensitive data does what it says it does, consistently, over time.
Here is what SOC 2 Type II actually is, why the "Type II" part is the one that counts, and what it means for your team.
What SOC 2 Type II is
SOC 2 — System and Organization Controls 2 — is a framework developed by the American Institute of Certified Public Accountants (AICPA) for evaluating how a service organization safeguards customer data. It measures controls against the AICPA's Trust Services Criteria, which span five areas: Security, Availability, Processing Integrity, Confidentiality, and Privacy. Security is the baseline that every SOC 2 examination covers; the others are included based on the scope of the engagement.
The important part is who does the evaluating. A SOC 2 report is not something a vendor grants itself. It is the result of an examination performed by an independent, licensed CPA firm that tests the controls and issues a formal report on what it found. You are not taking the vendor's word for it. You are taking an auditor's.
Point in time
Confirms the right controls exist on the day the auditor looked. A photograph of the lock on the door.
Over a sustained period
Proves those controls worked every day across the observation window — verified by an independent CPA examination.
Security
Availability
Processing Integrity
Confidentiality
Privacy
Faster security reviews
Point IT and infosec to the report instead of a long back-and-forth of questionnaires.
A stronger audit position
An independently attested vendor is far easier to defend in your own inspections than one on trust alone.
Ongoing assurance
Type II is maintained on a recurring cycle — a standard we hold continuously, not a milestone passed once.
SOC 2 complements — it doesn't replace. It attests to how the platform is secured and operated, alongside the frameworks you work under: 21 CFR Part 11, HIPAA, ISO, and GxP.
Why Type II is the one that matters
SOC 2 comes in two forms, and the difference is significant.
A Type I report evaluates whether controls are suitably designed at a single point in time. It is a snapshot. It tells you the right controls exist on the day the auditor looked.
A Type II report goes further. It evaluates whether those controls were not only designed properly but operated effectively across a sustained period, typically several months to a year. It is the difference between "we have a lock on the door" and "the lock was in place and working every day for [X] months, and an independent auditor verified it." Type II is what serious buyers ask for during vendor due diligence, because it speaks to how an organization actually runs, not just how it looks on a good day.
Kintavo's report covers a [observation period, e.g., 6-month / 12-month] examination period [conducted by [auditing CPA firm]], confirming our security controls operated effectively throughout.
Why this matters for a regulated eQMS
When you move your SOPs, CAPAs, deviations, training records, and audit trails into a cloud platform, that platform becomes part of your own compliance surface. Your auditors will ask how your vendors protect your data. Your information security and procurement teams will run vendor risk assessments. Your quality system has to account for the systems it depends on.
SOC 2 Type II gives you a clean answer to those questions. Instead of a questionnaire full of unverified vendor claims, you have an independent report you can hand to your IT, infosec, and audit teams. That shortens vendor reviews, strengthens your position in your own inspections, and removes one more unknown from your compliance picture.
It is worth being precise about what SOC 2 does and does not do. SOC 2 attests to how Kintavo secures and operates the platform. It complements — it does not replace — the regulatory frameworks your organization works under, such as 21 CFR Part 11, HIPAA, ISO standards, and GxP. Your validated use of the platform for its intended purpose remains yours. SOC 2 simply takes the question of "is the underlying platform secure and well-run?" off your plate, backed by an auditor's signature.
What this means for Kintavo customers
Faster security reviews. Point your IT and infosec teams to the report instead of fielding a long back-and-forth of questionnaires.
A stronger audit position. A vendor with an independent SOC 2 Type II report is far easier to defend in your own inspections than one operating on trust alone.
Ongoing assurance, not a one-time event. SOC 2 Type II is maintained on a recurring cycle. We do not treat security as a milestone we passed once. We treat it as a standard we hold continuously.
How to access the report
Kintavo's SOC 2 Type II report is available to current and prospective customers under a non-disclosure agreement. Contact us or your account team to request a copy, along with our broader security documentation.
Quality teams choose Kintavo because they cannot afford to have anything slip through the cracks — including the security of the system itself. SOC 2 Type II is one more way we make sure it does not.
Frequently asked questions
Is SOC 2 a certification? Not exactly. SOC 2 results in an independent attestation report issued by a licensed CPA firm, rather than a certificate or pass/fail seal. It is common to describe an organization as "SOC 2 compliant," but the underlying deliverable is an auditor's report on the organization's control?
What is the difference between SOC 2 Type I and Type II? Type I evaluates whether controls are properly designed at a single point in time. Type II evaluates whether those controls operated effectively over a sustained period, typically several months to a year. Type II provides stronger, ongoing assurance.
Does SOC 2 replace HIPAA, 21 CFR Part 11, or ISO compliance? No. SOC 2 attests to how the platform is secured and operated. It complements the regulatory frameworks your organization works under rather than replacing them.
How do I get a copy of Kintavo's SOC 2 Type II report? The report is available under a non-disclosure agreement. Contact your account team or info@kintavo.com to request it.
