Frequently Asked Questions
Is ZenQMS fully validated?
The ZenQMS platform is fully validated for GxP per GAMP 5 guidelines for a Category 3 system, 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 compliment of validation documentation, including validation plan, URS, FRS, IQ/OQ/PQ, Trace Matrix, etc.
Is ZenQMS Part 11 compliant?
Yes! Our electronic signatures are Part 11 and Annex 11 compliant, and we've got all of the validation data for you.
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.
Does ZenQMS own it's own servers?
We do not own our own servers, our application uses Amazon AWS. Learn More.
Does anything have to be downloaded or installed?
No, we work from your browser of choice with nothing to download or install locally to your computer.
How often is ZenQMS updated?
Major upgrades are released 3 times a year, and we provide release notes, validation documentation, and a test environment to all of our clients. All of our upgrades are provided to our clients free of charge.
How long does implementation take?
Our implementations are measured in days and weeks, not months and years. Our implementation specialists can move quickly, making implementation in 90 days or less very possible.
How long has ZenQMS been around?
We have been around since 2009.
What types of companies does ZenQMS work with?
Most of our clients are in the Life Science space: Pharmaceutical, Biotech, Medical Device, CROs, CMOs and more! Since our system is highly configurable, there is no company too large or too small to benefit from ZenQMS.