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Continuous complianceDataRegulations

Biopharma Company Saves $500k by Qualifying Salesforce

Case study on Biopharma Company Saves $500k by Qualifying Salesforce.

Client profile: Leading global biopharmaceutical company with more than $30B in annual revenue and over 8,000 employees running dozens of enterprise platforms.

Biopharma Company Saves $500k by Qualifying Salesforce graphic

Executive takeaway

USDM proved Salesforce could run in a qualified GxP state, saving the biopharma more than $500K in first-year license costs while delivering continuous cloud compliance.

First-Year Savings

$500k+

Saved in license costs in the first year by qualifying Salesforce for GxP instead of buying a separate validated platform.

Scale Supported

8,000+ employees

Compliance framework spanned dozens of platforms used across an organization with more than $30B in annual revenue.

Compliance State

Continuous

Cloud Assurance established baseline and automated testing to maintain a continuously compliant, GxP-ready Salesforce environment.

Before USDM

  • Entrenched belief that Salesforce could not be used in a qualified way for GxP.
  • Minimal cloud adoption for GxP use cases and no framework for validating cloud applications.
  • Facing significant license costs to stand up a separately validated platform.

After USDM

  • Salesforce optimized and qualified for GxP functionality across the enterprise.
  • A robust cloud compliance framework with risk-based validation and automated SQA testing.
  • More than $500K saved in first-year license costs with continuous cloud compliance maintained.

Challenge

A leading biopharma company with more than $30B in annual revenue and over 8,000 employees ran dozens of enterprise platforms but had only minimal cloud adoption for GxP use cases. An entrenched belief had taken hold across the organization: that Salesforce could not be used in a qualified way for regulated work.

The company had no compliance framework for assessing and maintaining a validated state for cloud-based applications. Without a defensible, risk-based approach to computer software assurance, the path of least resistance pointed toward standing up a separately validated platform — a move that carried significant new licensing costs and added system sprawl.

  • Leading biopharma company with more than $30B in annual revenue
  • Dozens of platforms used by more than 8,000 employees
  • Entrenched belief that Salesforce could not be used in a qualified way
  • Minimal cloud adoption for GxP use cases
  • No compliance framework for assessing and maintaining a validated state for cloud-based applications

Approach

USDM established a robust cloud compliance framework to manage risk, then qualified Salesforce for GxP use rather than replacing it. The cornerstone was Cloud Assurance for Salesforce, which created baseline and automated testing to keep the platform in a continuously compliant state.

On top of that foundation, USDM established risk-based validation commensurate with the system's intended use, regulatory rigor, technical complexity, business risk, and data integrity risk. The approach right-sized effort to actual risk instead of validating everything to the same depth.

What USDM Delivered

  • A robust cloud compliance framework to manage risks across regulated cloud applications
  • Cloud Assurance for Salesforce with baseline and automated testing to maintain continuous compliance
  • Risk-based validation aligned to intended use, regulatory rigor, technical complexity, business risk, and data integrity risk
  • Baseline qualification and validation deliverables provided through USDM's VAP
  • An annual Salesforce audit included as part of the subscription
  • Validation augmented by SQA (automated) testing and Functional Risk Assessments, with common capabilities qualified once and reused
  • Simplified end-use validation based on verifying configurations of common capabilities, user acceptance/PQs, and extensive validation reserved only for unique capabilities

By qualifying the underlying common features and functionality up front, USDM let the company validate end uses by simply verifying configurations — a pattern that supports ongoing 21 CFR Part 11 compliance as new use cases come online.

Results

Qualifying Salesforce — instead of buying and validating a separate platform — delivered measurable savings and a durable compliance posture.

  • $500k+ saved the first year in license costs
  • Continuous cloud compliance maintained through baseline and automated testing
  • Salesforce optimized and qualified for GxP functionality

The biopharma turned a platform its teams believed could never be qualified into a continuously compliant, GxP-ready system — proving that a disciplined continuous compliance approach can cut cost and risk at the same time. Talk to USDM about qualifying your cloud platforms for GxP use.

Qualify Your Cloud Platforms

Run Salesforce in a Continuously Compliant GxP State

See how USDM Cloud Assurance and risk-based validation can qualify your cloud applications for GxP use, reduce license spend, and keep you continuously compliant.

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