Discover a digital-forward approach to harmonize compliance and innovation
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Join us for an insightful webinar as we delve into the world of digital quality within the life sciences industry. In an era of rapid technological evolution, the demand for harmonizing compliance with technology has never been more crucial. This session spotlights the approach of USDM Integrated GxP Compliance—a modern managed service designed to simplify the way pharma, biotech, and medical device companies optimize their GxP operations and navigate the complexities of compliance to accelerate innovation.
What You'll Learn
- How a digital quality approach reframes quality and compliance as a driver of innovation rather than a barrier to it.
- Practical GxP use cases that accelerate digital transformation across life sciences domains.
- How Integrated GxP Compliance maintains compliance across both regulated cloud applications and on-premises IT systems as a single managed service.
- How automation in validation and application lifecycle management minimizes validation burdens and supports continuous compliance.
- A value-model case study showing the cost savings and operational efficiency the Integrated GxP Compliance model can deliver.
Inside the Webinar
This webinar explores:
- Digital Quality: A modern approach to quality and compliance that fuels innovation.
- GxP Use Cases: To accelerate your digital transformation across life sciences domains.
- Integrated GxP Compliance: A catalyst for innovation and continuous improvement, maintaining compliance across regulated cloud applications and on-premises IT systems.
- Unparalleled Compliance with Automation: USDM's progressive validation and application lifecycle solutions that minimize your validation burdens by automating testing activities and ensuring continuous compliance.
- Value Model for Transformational Outcomes: Hear a case study for the USDM Integrated GxP Compliance model that delivered substantial cost savings and improved operational efficiency.
Underpinning each of these themes are the core regulatory expectations that govern GxP systems—from 21 CFR Part 11 compliance for electronic records and signatures to the FDA's risk-based Computer Software Assurance (CSA) approach that reframes how validation effort is targeted and automated.
Why This Matters
For life sciences companies, compliance and innovation are too often treated as opposing forces—every new cloud application or system change becomes another validation burden. USDM's point of view is that they don't have to be. By treating quality as a digital capability and folding cloud and on-premises systems into a single managed service, Integrated GxP Compliance turns continuous compliance into a foundation for moving faster, not a tax on change. Automating testing and validation activities is what makes that durable: it keeps systems in a validated state while freeing teams to focus on the transformation work that actually advances the business.
Watch a Clip
Hear in this clip USDM co-founder Vega Finucan on the benefits we've provided to a top pharma manufacturing company.
Meet the Experts
Join our experts:
- Vega Finucan, Co-Founder and Managing Partner
- Hovsep Kirikian, VP of Strategy and Operations
Frequently Asked Questions About Integrated GxP Compliance
What is USDM Integrated GxP Compliance?
It is a modern managed service designed to simplify how pharma, biotech, and medical device companies optimize their GxP operations. It harmonizes compliance with technology so organizations can navigate regulatory complexity while accelerating innovation, rather than treating the two as competing priorities.
Does Integrated GxP Compliance cover both cloud and on-premises systems?
Yes. The service is built to maintain compliance across both regulated cloud applications and on-premises IT systems, bringing them together under a single approach to quality and continuous improvement. You can learn more about USDM's continuous compliance model through USDM Cloud Assurance.
How does automation reduce the validation burden?
The webinar covers USDM's validation and application lifecycle solutions, which automate testing activities to minimize validation effort and keep systems in a continuously compliant state. This aligns with risk-based regulatory frameworks such as Computer Software Assurance (CSA), which focuses validation effort where patient and product risk is highest.
What kind of results does the model deliver?
The session walks through a value-model case study for the Integrated GxP Compliance model that delivered substantial cost savings and improved operational efficiency—illustrating how a digital quality approach can produce transformational outcomes.
Who should watch this webinar?
Quality, compliance, IT, and operations leaders at pharma, biotech, and medical device companies who are looking to modernize their GxP operations, reduce validation overhead, and accelerate digital transformation while staying compliant.
Watch the Webinar On-Demand
Don't miss this opportunity to gain valuable insights into the future of GxP compliance and its integration with technological innovation. Fill out the form above to watch the full webinar on-demand and see how Integrated GxP Compliance can support a digital-forward quality strategy. To discuss how this approach applies to your systems, contact our team. You may also want to explore data integrity in life sciences for a deeper look at the foundations of GxP compliance.
