Learn how USDM deployed Computer Software Assurance (CSA) methodologies to drive meaningful efficiencies for a large biotech customer. By accelerating the utilization of an existing IT platform for additional GxP use cases, USDM was able to help the customer retire a legacy system and processes to gain significant efficiencies across the organization.

The Situation
  • Large biotech company
  • 100B in revenue
  • Departments engaged IT, Quality, and Informatics
  • Customer using Force.com platform for non-GxP processes
  • Customer wanted to qualify Force.com to enable the implementation and validation of a 3rd party complaint handling system to replace a legacy system
  • Customer also wanted to use Force.com for a custom sample management application to be rolled out to account managers nationwide 
  • Both use cases had to comply with 21 CFR Parts 11 and 203
The Solution
  • USDM was hired to implement and validate the 3rd party complaint handling system and develop and validate the custom sample management application
    • Additionally, the Force.com platform required qualification to be able to support GxP processes
  • USDM assessed the customer's data centers, network, security, quality systems and processes, training, audit trail, data retention processes, and change control systems and tools
  • USDM established the initial qualifiable state of the Force.com infrastructure
  • USDM utilized a CSA methodology to ensure appropriate controls for maintenance of the qualified state including; Force.com audit, review of standard change controls, verification of communication and system administration processes, development of robust SLAs, and creation of baseline configuration specifications for all GxP elements of the system
  • USDM also managed Force.com releases by performing a detailed analysis of the changes ahead of production release to ensure no adverse effects on existing functionality including; risk assessment, creation of new requirements, execution of new and regression testing protocols, and reporting
  • USDM also helped create internal policies for change control and validation to support new functionality of the systems including validation configuration processes and regular regression testing that could be utilized for future cloud systems
  • USDM developed a mobile iOS application that synced with Force.com to support sample disbursements
  • USDM developed a best-in-class SDLC that all parties worked within and can be utilized with future cloud vendors
  • USDM developed critical SLAs for transparency and protection
  • USDM enabled customer to utilized 3rd party assurance activities saving time and money

Utilized CSA methodologies to drive meaningful GxP process efficiencies

50% decrease in validation cost and time

Significantly reduced testing overhead

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