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.