Frequently Asked Questions
Is ZenQMS fully validated?
The ZenQMS platform is fully validated for GxP per GAMP 5 guidelines for a Category 4 system (e.g. Configurable Software), and FDA General Principles of System Validation: Final Guidance for Industry and FDA Staff, January 11, 2002. Every release is managed by ZenQMS staff under change control and includes a full complement of validation documentation, including validation plan, requirements and traceability mapping, IQ/OQ/PQ, etc.
Is ZenQMS Part 11 compliant?
Yes! Our electronic signatures are Part 11 and Annex 11 compliant. This is a critical part of our functional validation and we also provide a full Part 11 / Annex 11 check list that maps to the key standards.
Is ZenQMS audited directly by any regulatory agencies or certification authorities (e.g. FDA, ISO, etc.)?
We are not certified by any regulatory agencies or certification authorities. However our clients are, and as such all clients regularly audit ZenQMS for compliance with all applicable GxP guidelines and key certifications. Moreover, our infrastructure partner (AWS) does maintain many certifications and inbound regulatory and certifications audits, including SSAE 16 reports (SOC 1/2/3) and ISO 27001.
Where is my data hosted?
We have partnered with Amazon Web Services (AWS) to host our application and database servers. Amazon has consistently led all players in the infrastructure hosting category in terms of offerings, security and scalability, and ZenQMS benefits from this. Learn More.
Do I have to download or install ZenQMS?
No, because we are cloud-based, you can access ZenQMS from your browser and device of your choice. In addition to not having to install our software locally, you will always receive access to the latest updates.
How often is ZenQMS updated?
We release major upgrades 2-4 times per year. Each release will be announced in advance per terms set forth in our Quality Technical Agreement, and we provide a detailed list of updates, validation documentation, and a test environment specific to your account. Our goal is to best serve the ZenQMS community with our updates so much of our roadmap is co-created directly with our customers.
How soon can I start using ZenQMS? What’s implementation like?
We measure implementation in days and weeks not months and years. Our goal is to transition your quality practices to our system as smoothly and quickly as possible. As soon as you join the ZenQMS community, you will be assigned a dedicated project manager who will guide you through the implementation process. We expect to implement all clients to go live on the first milestone within 30-90 days, and work to meet your time constraints regardless.
How long has ZenQMS been around?
We were founded in 2009 by two founders who spent years in the CMO/CRO space or the clinical IVRS space.
What types of companies does ZenQMS work with?
The ZenQMS community is focused on Life Sciences with companies innovating in Pharmaceuticals, Biotech, Medical Device, CROs, and CMOs to name a few. We have a team of subject matter experts who can speak to your specific needs as well as seasoned project managers to guide you through your implementation.
What is the typical size of the companies ZenQMS works with?
We believe that best practices should be scalable. Our configurable and robust system is built to grow with you, whether you are a small start up in the lab or a large, integrated commercial company with thousands of employees in dozens of locations around the world-- ZenQMS can support you.