Making it easier to qualify and maintain your quality management system with ZenQMS and USDM Life Sciences
Fill out the form to watch the full-length on-demand webinar.
Quality teams have been afraid of what they don't know for too long when selecting, auditing, and qualifying cloud-based software systems to achieve their GxP business requirements. This fear of the unknown often leads to poor software decisions, over-validating those systems, and creating complex internal processes that keep the Quality and IT teams at odds. ZenQMS and USDM believe that life sciences companies should have a simple pathway to onboarding, qualifying, and implementing IT systems that support critical quality business requirements.
In this on-demand webinar, you will learn about ZenQMS's unique approach to efficient quality management with compliance and customer experience at the forefront of its strategy.
What you'll learn
- How to harmonize your quality and technology business requirements so Quality and IT teams stop working at odds.
- Practical considerations for selecting cloud-based GxP technologies without over-validating them.
- How ZenQMS approaches quality management with a platform built to be easy to acquire, implement, validate, and use.
- How USDM's Cloud Assurance Certification and Vendor Assurance Report let you leverage vendor activities to minimize your own validation effort.
- Answers from a live Q&A with the ZenQMS CEO on real-world eQMS qualification questions.
Watch a clip from the session
Watch this short clip from the webinar to hear Panos Boudouvas, Co-Founder & CEO of ZenQMS, discuss the value of USDM's Cloud Assurance Certification and the accompanying Vendor Assurance Report.
Inside the webinar
The full-length session covers the following discussions:
- Guidance for harmonizing your quality and technology business requirements
- Considerations for selecting your cloud-based GxP technologies
- ZenQMS's unique approach to quality management, rooted in a platform that is easy to acquire, implement, validate, and use
- USDM's Cloud Assurance Certification and how you can leverage vendor activities to minimize your validation burdens
- Live Q&A with the ZenQMS CEO
Why this matters
For regulated life sciences companies, the cost of an eQMS isn't the license — it's the validation overhead and the friction between Quality and IT. USDM's point of view is that you shouldn't re-prove what a qualified vendor has already demonstrated. By pairing a purpose-built eQMS with a structured vendor assessment, you can adopt cloud GxP systems with confidence, keep them in a validated state over time, and redirect quality resources toward the work that actually reduces risk. Approaches like Computer Software Assurance (CSA) and USDM Cloud Assurance reflect that same shift — from documentation for its own sake to risk-based, evidence-driven compliance.
Presenters
David Blewit, VP Cloud Compliance, USDM Life Sciences
David is an accomplished life sciences regulatory and IS compliance professional with 30+ years of experience in the pharmaceutical, medical device, biotech, and blood management industries. David leads the rigorous compliance, security, and data integrity assessments technology vendors must undergo to become Cloud Assurance Certified.
Panos Boudouvas, Co-Founder & CEO, ZenQMS
Panos started ZenQMS to provide quality professionals with better eQMS tools for enhanced compliance at an affordable price. He previously served in multiple executive roles at Aptuit, a leading Pharma CRO/CMO, and in Private Equity and Investment Banking firms, focusing on the pharmaceutical, healthcare services, and technology industries.
FAQ: Simplifying GxP quality assurance
What is an eQMS and why qualify it for GxP?
An electronic quality management system (eQMS) digitizes core quality processes for regulated life sciences companies. Because it supports GxP business requirements, it has to be selected, qualified, and validated so you can demonstrate the system performs as intended and your records are trustworthy. The webinar focuses on making that pathway simpler rather than more complex.
How does USDM's Cloud Assurance Certification reduce my validation burden?
When a technology vendor undergoes USDM's rigorous compliance, security, and data integrity assessments to become Cloud Assurance Certified, the resulting Vendor Assurance Report lets you leverage those vendor activities instead of re-performing them yourself. The session explains how that shifts effort off your Quality and IT teams. You can learn more about USDM Cloud Assurance.
Why do Quality and IT teams end up at odds over cloud software?
Fear of the unknown when auditing and qualifying cloud systems often drives over-validation and complex internal processes. As the speakers discuss, harmonizing quality and technology business requirements up front keeps the two teams aligned and avoids unnecessary work.
How does this relate to data integrity and 21 CFR Part 11?
Qualifying a GxP system means having confidence in the integrity of the electronic records and signatures it manages. The selection and validation considerations covered here connect directly to data integrity expectations and 21 CFR Part 11 compliance.
Is this webinar still relevant if I'm only beginning to evaluate an eQMS?
Yes. The session is framed around selecting, onboarding, qualifying, and implementing cloud-based GxP systems, so it's useful whether you're early in vendor evaluation or already planning a validation. You can watch the full session on demand and reach out to USDM with your specific scenario.
Watch the full on-demand webinar
Fill out the form to watch the full-length session with David Blewit and Panos Boudouvas, including the live Q&A. Want to talk through your own eQMS selection or validation strategy? Contact USDM Life Sciences to connect with our cloud compliance team.