Long-Term
CQV and Validation Program Support
Location: Birmingham, AL
Project Overview
For more than a decade, Compli has provided commissioning, qualification and validation (CQV) support at a specialty life sciences manufacturing facility in Birmingham, Alabama. Compli has helped manage and evolve the site’s validation and quality systems to meet ongoing regulatory and operational demands.
Scope of Services
Compli’s involvement began with risk assessments, Critical Process Parameter (CPP) determinations and sterility assurance evaluations for aseptic operations. These efforts quickly expanded to include equipment and product risk assessments, media fill strategy development, protocol authorship and data trending support.
Technical Execution
As the client’s validation needs grew, Compli played an integral role in the full validation lifecycle for aseptic fill lines, from design input and User Requirements Specification (URS) development to Factory and Site Acceptance Testing (FAT/SAT), Installation and Operational Qualification (IOQ), Performance Qualification (PQ), Cleaning Validation and Process Validation. The team also provided temporary department management support by stepping in as acting Validation Manager during a leadership transition.
Additional Contribution
Compli’s technical team has supported a wide range of CQV and regulatory requirements across facilities, utilities, equipment, cleaning procedures, computer systems and production processes. In addition to managing project execution, Compli also helped build and improve the site’s Validation Quality System and supported capital project estimating efforts.
Ongoing Partnership
The strength of Compli’s personnel and subject matter expertise has enabled the successful delivery of uninterrupted service for over 12 years, demonstrating our commitment to quality, consistency, and long-term client partnerships.