Learn how USDM’s Compliance-as-a-Service model transformed the compliance program of a Fortune 1000 medical device company needing a compliance strategy overhaul.
USDM deployed a Compliance-as-a-Service program and restructured numerous GxP processes to achieve corporate-wide validation consistency while reducing validation timelines and overall costs.
The Situation
- Fortune 1000 medical device manufacturer with 15k products globally
- Compliance activities had grown significantly
- No corporate standard for validation
- CSV methodology mistakenly being applied to product validation
- Too many compliance vendors with no ownership
- Inconsistent documentation approach with many gaps in compliance requirements
- Recent offshore outsourcing of change control and change control traceability was inadequate
- Quality leadership wanted holistic, corporate–wide visibility of the status of compliance
The Solution
Deployed USDM's Compliance-as-a-Service program with the following key activites:
- Set up new corporate-wide governance program
- Assembled business, quality, technical owners to drive alignment
- USDM took 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
- Ongoing Operations – USDM provides weekly, monthly and quarterly metrics to stakeholders in a variety of meetings
The Results
Large ERP project effort reduced:
- 50% fewer resources required
- 50% faster delivery
- Delivered 60% more functionality once reaching steady state