Overview
A Fortune 1000 medical device manufacturer with roughly 15,000 products distributed globally needed a complete compliance strategy overhaul. USDM deployed its Compliance-as-a-Service model and restructured numerous GxP processes to achieve corporate-wide validation consistency while reducing validation timelines and overall costs.
The Challenge
As the company grew, its compliance activities grew with it — but without the structure to keep them consistent. Quality leadership wanted holistic, corporate-wide visibility into the status of compliance, and the existing environment made that impossible.
- Compliance activities had grown significantly with no corporate standard for validation
- CSV methodology was mistakenly being applied to product validation
- Too many compliance vendors with no clear ownership
- An inconsistent documentation approach left many gaps against compliance requirements
- Recent offshore outsourcing of change control left change control traceability inadequate — a clear third-party risk exposure
- No corporate-wide way for quality leadership to see the true status of compliance
The Approach
USDM deployed its Compliance-as-a-Service program to centralize all compliance activities and oversight under a single accountable model. Rather than coordinating a patchwork of vendors, the customer gained one partner that took ownership of the full quality landscape.
Establish governance and ownership
- Stood up a new corporate-wide governance program and assembled business, quality, and technical owners to drive alignment
- USDM took ownership of all quality functions, including infrastructure maintenance and performance, systems development and CSV projects, SOP and process improvements, data integrity and security, systems upgrades and decommissions, site-based QA and CSV, and data center and site remediation
- Scheduled weekly, monthly, and quarterly meetings with stakeholders — with monthly and quarterly reviews reaching VP and C-level leaders
Standardize validation and change control
- Ran a Quality System process improvement workstream during initiation to assess current systems for gaps
- Defined a single corporate standard for validation across enterprise systems, manufacturing, and infrastructure — correcting the prior misapplication of CSV to product validation and aligning the program with a modern risk-based assurance mindset
- Implemented ITIL methodology for change control to restore traceability lost during offshore outsourcing
- Used Organizational Change Management to drive the new standards down to division and site levels
Run it as an ongoing service
In ongoing operations, USDM provides weekly, monthly, and quarterly metrics to stakeholders across a variety of meetings — giving quality leadership the corporate-wide visibility they had been missing and keeping the program in a state of continuous compliance.
The Results
Centralizing compliance under one governance model and one validation standard paid off most visibly on a large ERP project effort, where the same scope was delivered with dramatically less overhead:
- 50% fewer resources required
- 50% faster delivery
- 60% more functionality delivered once the program reached steady state
By trading a fragmented, multi-vendor compliance program for an accountable Compliance-as-a-Service model, the manufacturer achieved corporate-wide validation consistency, restored change control traceability, and gave quality leadership the holistic visibility it needed — while reducing validation timelines and overall cost.