ZenQMS doesn’t develop drugs or devices directly, but all of our clients do. So while we may never be directly audited by a regulator, our clients are being audited. We know how critical our software is in those moments and your day-to-day activities, so it's our job to be more thoughtful than our most conservative, at-risk clients. We believe any SaaS services not taking the same proactive approach are selling half a solution and putting a client's quality profile at risk in the process.
ISO 9001:2015, ISO 27001:2013, and USDM Cloud Assurance certifications, along with a SOC 2 Type II report are the international standards you should expect of any quality SaaS vendor. Anything less and you could be putting your data at risk for stability, integrity, and privacy issues.
In addition to maintaining these certifications, ZenQMS’ quality system is audited more than a hundred times each year by experienced client auditors. And with hundreds of clients around the world from preclinical/clinical innovators to fully commercial stage GxP manufacturers, we know just how well ZenQMS holds up to scrutiny.
For regulated companies, maintaining valid electronic signatures and audit trails is a key risk factor when using an eQMS, even for very early stage companies. This means meeting the stringent requirements set forth in 21 CFR Part 11 and EU Annex 11 standards for software validation are non-negotiable. Clients can expect a seamless audit trail for all transactions, a quarterly QA validation package for this endpoint, and a separate assessment and p. 11/ Annex 11 checklist they can download.
Clients can also expect that ZenQMS takes a conservative GAMP 5 (Category 4)-driven approach to validation, wholly consistent with new FDA guidance for Computer Software Assurance (CSA). We encourage all clients to leverage our validation materials rather than starting from scratch. To that end, we share all validation documents and provide UAT templates to clients at no charge. Our goal is to make sure our customers (even those with limited resources) can validate our software and navigate the UAT in just a few days.
Data privacy and security have emerged as a critical risk factor for companies using electronic systems. As these global provisions evolve, ZenQMS continues to take a proactive approach to ensure out-of-the-box compliance for all customers with no extra effort. Together with our turnkey implementation services, in-house support, and intuitive platform, we make it easy to get up and running with a secure, user-friendly eQMS that you can trust.
ZenQMS maintains a single, validated, multi-tenant instance in the cloud at all times, hosted by Amazon Web Services (AWS), the only commercial cloud vetted and accepted as secure enough for top-secret workloads. This translates to > 99.99% uptime going back more than 10 years and a robust approach to Business Continuity and Disaster Recovery that mitigates data loss.