Case Study: Mastering Manufacturing Compliance

access_timeApril 25, 2024
by  Michelle Bonn

About The Client

Compliance Team worked with a manufacturer of solutions for analysis of genetic variation and function; an FDA-regulated medical device manufacturer.

The Problem

The client’s space was spread across two outgrown rented sites, set approximately five miles apart. To accommodate business growth and to consolidate operations under a single roof, a new building was constructed. But, with the new construction, came the issue of ensuring that everything was compliant.

The Vision

The client wanted to hire someone to qualify the facilities, utilities, and significant quantities of process and laboratory equipment, including 100 cold storage units, relocated analytical instruments and manufacturing equipment, as well as new capital equipment purchased for use in the new building, a total of 200+ systems.

Author the Quality Plan, a Validation Master Plan, Validation Plans, Validation Risk Assessments, and the Validation Project Plan for all of these systems. The low-risk nature of the products presented an opportunity for novel qualification approaches, such as bracketing, and use of the most challenging products as a test case for all.

As the project progressed, the client identified a need for Quality support in reviewing and approving validation documents. Then, they identified a need for Metrology support to ensure that nonqualified equipment was properly cataloged in the maintenance system and that all pre-move and post-move checks were properly documented.

The Solution

Compliance Team was hired and was able to provide a risk-based science-based rationale for these approaches and was credited for having the flexibility to understand and implement the various risk-based options for the successful qualification and validation effort.

The move and requalification project was completed on schedule and the client now enjoys its building that houses a collaborative workspace where all operations are consolidated under one roof.  Eventually, the validation manager was promoted for having led the successful effort!