In an increasingly digital, data-driven world, the security and integrity of information are non-negotiable — especially in regulated industries like pharmaceuticals, biotech, and medtech. Trust in data is fundamental to trust in decisions, and nowhere is this more critical than in managing third-party risk across global supply chains.
At Qualifyze, we’re proud to share that we’ve achieved SOC 2 Type II certification, a gold standard in data security and operational excellence. But what exactly does this mean? And how does it benefit life sciences organizations relying on Qualifyze for audit services and supplier risk insights?
What Is SOC 2?
SOC 2 (System and Organization Controls 2) is a globally recognized auditing standard developed by the American Institute of Certified Public Accountants (AICPA). It is specifically designed for service organizations that handle customer data — evaluating their controls across five Trust Services Criteria (TSC):
- Security – Protecting systems from unauthorized access.
- Availability – Ensuring systems are operational and available as agreed.
- Processing Integrity – Guaranteeing that system processing is complete, valid, accurate, and timely.
- Confidentiality – Protecting sensitive information from unauthorized disclosure.
- Privacy – Ensuring proper handling and protection of personal data.
There are two types of SOC 2 audits:
- Type I evaluates whether the required controls exist and are properly designed — at a single point in time.
- Type II goes further, assessing how well those controls operate over a sustained period.
By achieving SOC 2 Type II, Qualifyze has demonstrated not only that the right processes and policies are in place — but also that they work in practice, consistently and reliably.
What Is Assessed — and How?
SOC 2 Type II audits are comprehensive, involving hundreds of pages of documentation, interviews, and technical validation. Here’s a breakdown of what was examined:
Security Controls
The foundation of SOC 2, these include: identity and access management, system configuration and hardening, encryption in transit and at rest, intrusion detection and response, employee onboarding and offboarding, security awareness and training, vulnerability management and patching
System Monitoring & Incident Response
SOC 2 auditors look for clear evidence that systems are being monitored continuously, and that there are well-defined procedures for handling security events. For example: logs and audit trails, automated alerts, defined response plans, post-incident reviews.
Policy Documentation
SOC 2 requires extensive documentation. Companies must prove they have formal policies that are regularly reviewed and enforced, covering areas such as data classification, change management, vendor risk management, backup.
Evidence Collection
Auditors don’t just analyze procedures — they collect evidence. This might include access logs, ticketing system records, employee training logs, test results from disaster recovery drills, and more.
At the end of the assessment, the auditor provides a detailed SOC 2 report confirming whether the organization meets the criteria and how well controls operated during the review period.
Why SOC 2 Type II Matters for Life Sciences
Supplier Risk Demands Strong Data Assurance
Life sciences companies rely on secure, accurate, and timely audit data to make compliance decisions — often across vast, global supply networks.
SOC 2 Type II certification assures our customers that Qualifyze operates with the same level of data discipline and integrity they expect internally. It reinforces the credibility of the audit data and risk scores we provide, which are foundational to quality oversight and inspection readiness.
Reducing Vendor Risk for Our Customers
Every time a pharma or medtech company works with a third-party service provider like Qualifyze, they take on vendor risk. SOC 2 Type II allows our customers to simplify their own due diligence processes.
Instead of conducting extensive IT and security assessments of our platform, our SOC 2 report provides an independently audited confirmation that we’re meeting best practices in data protection and system reliability.
Demonstrating Our Commitment to Operational Excellence
SOC 2 Type II isn’t a one-time achievement — it’s a demonstration of ongoing operational maturity. Passing the audit means that Qualifyze maintains rigorous internal controls while continuously improving its technology and processes.
A Strategic Differentiator
Our certification is more than a compliance checkbox — it’s a signal to our customers and partners that Qualifyze takes security, quality, and trust seriously.
We operate in a space where data handling, confidentiality, and continuity are vital. Whether you’re a global pharma company or a fast-growing biotech, knowing that your audit partner is independently certified is a compliance guarantee.
For you as for us, the cost of poor data quality or system failure isn’t just financial — it could mean regulatory setbacks, delays or safety risks.
If you’d like to access our SOC 2 report find it here.