Coda Corp USA provides Quality Systems development and implementation, Regulatory Compliance, Validation, Training, and Auditing services to the pharmaceutical, biotech, and medical device industries in accordance with CFR Title 21 and all associated legal rulings.  Our internal processes and our services have been developed with the Quality By Design models of the modern Quality System.  Coda executives believe in, and Coda practices reflect, the fundamental tenets of quality systems.  The following are analyses of projects that highlight Coda’s knowledge, experience, and ability to assist clients in meeting/exceeding their project goals.    [each header should click to expand full text?]

[Please see Coda Corp USA Case Studies document for full text.]

Global LIMS Implementation

LIMS, Project Management, Part 11

Global LIMS Implementation/Quality System Development/Procedure Development (a corrective action required in accordance to a Federal Injunction):

The Coda PM was responsible for defining, planning, budgeting (see Focus Detail 1), resource loading, tracking and administering the following stages of this critical project for a client that was, at the time, the world’s largest Pharmaceutical Manufacturer.  Coda’s commitment to the project was made and when the client did not have a central group to support or staff the effort.  The Coda PM was responsible for …