Multi-Year Support for
Validation and Program Management Services
Location: Central Michigan
Timeline: 2018 – Present
Project Overview
Since 2018, Compli has supported a confidential client in Central Michigan through a range of services focused on regulatory compliance and capital project execution. The engagement includes Validation Quality Systems development, Program Management for multiple capital expenditure (Capex) initiatives, periodic equipment requalification’s and remediation support for the client’s Data Integrity program.
Scope of Services
Compli provided a flexible team structure, scaling as many as five on-site professionals, depending on project needs. Services included:
- Validation Quality Systems: Establishment and refinement of validation processes to support compliant operations.
- Program Management: Oversight and coordination of several Capex projects, ensuring successful delivery aligned with regulatory and operational goals.
- Equipment Requalification: Performance of scheduled requalification activities to maintain equipment validation status.
- Data Integrity Remediation: Support in addressing data integrity gaps, including implementation of procedural and system improvements.
Project Challenges and Solutions
Managing Program Management and Data Integrity efforts across multiple departments required gaining alignment among diverse stakeholders. Compli’s team navigated these complexities through clear communication, strategic coordination and strong interpersonal engagement—facilitating consensus and driving projects forward.
Why Compli
Building on successful past collaborations with Compli personnel at other facilities and confidence in the team’s specialized expertise, the client established a trusted, multi-year partnership focused on mission-critical compliance and operational initiatives.