Compliance as a Service reduced ERP timelines by 50%

Learn how USDM’s Compliance as a Service model transformed the compliance program of a Fortune 1000 medical device company in total compliance disarray. USDM deployed Compliance as a Service, restructured numerous processes to achieve corporate-wide validation consistency while reducing validation timelines and overall costs.  

Read on to find out how USDM reduced costs and mitigated regulatory risk, positioning a once troubled company for streamlined operations and success in the face of future agency audits.  
 

The Situation

Client compliance activities throughout the enterprise had grown significantly:
  • No corporate standard for validation (and periodic review)
  • Validation levels at different sites varied significantly – CSV methodology was being applied to product validation
  • Too many compliance vendors with no point of ownership with many different approaches in documentation and varying levels of consistency and general compliance gaps in documentation
  • Recent offshore outsourcing of change control and change control traceability was weak
  • Quality leadership wanted corporate–wide visibility of the status of compliance
The scope included 32 enterprise systems and infrastructure with the following activities:
  • Infrastructure Maintenance / Performance
  • Systems Development and CSV Projects
  • SOP and Process Improvements
  • Data Integrity / Security
  • Systems Upgrades / De-commissions
  • Site based QA / CSV
  • Data Center and Site Remedia

The Solution

Deployed USDM’s Compliance as a Service with the following key activities:
  • Set up new corporate program that provided governance to the sites.
  • Assembled business, quality, technical owners and got everyone on board.
  • Assumed ownership of all quality functions:
    • Infrastructure Maintenance / Performance
    • Systems Development and CSV Projects
    • SOP and Process Improvements
    • Data Integrity / Security
    • Systems Upgrades / De-commissions
    • Site based QA / CSV
    • Data Center and Site Remediation
Scheduled weekly, monthly and quarterly meetings with various stakeholders. Monthly and quarterly include VP and C levels.

Scope of the work included:
  • Rolled out Compliance as a Service that would centralize all compliance activities and oversight.
  • Initiation - The program involved a Quality System process improvement workstream as part of the initiation phase with the following activities:
    • Assess current systems for gaps
    • Defined corporate standard for validation and enterprise systems, manufacturing and infrastructure; Implemented ITIL methodology for change control.
    • Organizational Change Management drove standards down to division and site levels
  • Transition and taking over ownership of all quality operations
  • ​Ongoing Operations – USDM provides weekly, monthly and quarterly metrics to stakeholders in a variety of meetings.

50% Shorter time to deploy AND 50% fewer resources required for large ERP project

Large ERP project effort reduced:

  • Required 50% fewer resources
  • Delivered in 50% less time after reaching steady state (18 months to 13 months to 9 months)
  • Delivered 60% more functionality once reaching steady state

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