Learn how you can automate and scale your regulated business processes while maintaining compliance.
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In this webinar
Regulated life sciences teams often run critical GxP processes on paper, email, and spreadsheets long after the rest of the business has gone digital. This on-demand webinar walks through how USDM customized workflows for three different organizations — a start-up biotech, a Top 20 global pharma, and a recently commercialized biopharma — to automate and scale those processes while preserving 21 CFR Part 11 e-signatures, audit trails, and continuous compliance.
Watch this webinar to learn how USDM customized various workflows, demonstrated a framework for continuous compliance, and responded to detailed questions about regulatory requirements to automate and simplify the business processes for each of these customers in these case studies. We can do this and more for you, too.
The customer case studies
- A start-up biotech company with minimal IT systems in place required a solution for regulated GxP IT change management and user access provisioning.
- A Top 20 global pharma company had a variety of regulated paper-based forms and processes to digitize and needed a trusted, 21 CFR Part 11 compliant solution that would pass an FDA audit.
- A recently commercialized biopharma struggled to leverage its platform for regulated use and was frustrated with the lack of regulatory expertise from the vendor.
What this discussion addresses
- Managing GxP and non-GxP processes in one platform
- Solving for 21 CFR Part 11 eSignatures and audit trails
- Automating and scaling your business processes while maintaining compliance
- Gaining greater insight into your product lifecycle
Why compliance can’t be an afterthought: Automating a regulated workflow is only half the work. The other half is proving — to an auditor — that the automated process still enforces the same controls the paper process did. That means validated configuration, electronic records that meet 21 CFR Part 11 requirements, and a defensible audit trail for every change. A risk-based Computer Software Assurance (CSA) approach lets you focus testing effort where patient safety and data integrity risk actually live, instead of validating everything equally.
A framework for continuous compliance
Digitizing a GxP process is not a one-time project. Platforms get patched, configurations drift, and new regulations land. Keeping an automated workflow in a validated, inspection-ready state over time depends on three things working together.
1. Validate the configuration
Apply a risk-based, CSA-aligned method so testing rigor matches the GxP impact of each workflow — not a blanket script for every form and field.
2. Enforce Part 11 controls by design
Bake electronic signatures, identity verification, and immutable audit trails into the workflow itself so compliance is a property of the system, not a manual step someone can skip.
3. Keep it compliant over its lifecycle
Treat validation as ongoing. Validation lifecycle management and Cloud Assurance keep digitized processes audit-ready as the underlying platform and your business evolve.
Automation without governance just digitizes risk faster. The goal is a workflow an FDA auditor can trust as much as the paper it replaced.
Why data integrity matters for digitized GxP workflows
When a regulated form moves from paper to a platform, every captured record becomes part of your compliance evidence. That makes data integrity — ensuring records are attributable, legible, contemporaneous, original, and accurate — central to whether the automated process holds up under audit. The same controls that make a workflow efficient should make its data defensible.
Watch the webinar video below:
Presenters
Vega Finucan, Co-Founder and Managing Partner, USDM Life Sciences
Vishal Sharma, Vice President of Digital Trust and Transformation, USDM Life Sciences
Additional Resources
FAQ: Automating regulated GxP workflows
Can I manage both GxP and non-GxP processes on one platform?
Yes. A core theme of this webinar is managing GxP and non-GxP processes in a single platform, applying the appropriate compliance controls only where they are required so regulated and unregulated work can coexist without over-engineering everything.
How do automated workflows satisfy 21 CFR Part 11?
By building electronic signatures and audit trails into the workflow itself. The webinar covers solving for 21 CFR Part 11 eSignatures and audit trails so a digitized form or approval meets the same regulatory expectations — and can pass an FDA audit — as its paper predecessor.
What kinds of GxP processes can be automated?
The case studies span regulated IT change management, user access provisioning, and digitizing paper-based forms and processes. The common thread is taking a manual, regulated business process and automating it while maintaining compliance.
How do you keep an automated GxP process compliant over time?
Through a framework for continuous compliance: risk-based validation, Part 11 controls enforced by design, and ongoing validation lifecycle management so the workflow stays inspection-ready as the platform and your business change.
What if our current vendor lacks regulatory expertise?
That was exactly the challenge for one of the featured customers — a recently commercialized biopharma frustrated by a vendor that could not support regulated use. USDM brings the regulatory and validation expertise to configure, validate, and maintain the platform for GxP use.
Ready to automate your regulated processes?
USDM can customize and validate workflows that automate your GxP and non-GxP processes while keeping them audit-ready and compliant. Contact us to talk through your use case, or explore our Cloud Assurance approach to keeping digitized systems continuously compliant.