Case Study: Pharmaceutical

In 2003 THINQ was engaged to validate an implementation of JD Edwards OneWorld application at the customer’s New Jersey facilities. Part of the drive for change related to recent FDA audit findings, especially in relation to manufacturing operations. THINQ compliance experts formed part of the project team integrating compliance methodologies into the project implementation.

The project was constructed into three main phases spanning nearly 2 years in implementation and validation. By the time it was completed it included warehouse barcoding, advanced warehousing features and enterprise resource planning. In addition, THINQ used its THINQ Compliance Manager software© (TCM) to manage all compliance content.

During the project THINQ:

Performed vendor audits at all software suppliers.
Managed the compliance content for almost 50 different controlled documents using TCM.
Automatically created a traceability matrix that tracked thousands of requirements, design and configuration documents and tests, marking them suspect when compliance content changed.
Qualified an IT infrastructure to COBIT standards, writing more than 40 specific Standard Operating Procedures for IT staff including an ‘in project’ and final (workable!) change control process.
Completed the project on time and within budget based on a fixed price submitted at the start of the project.
Performed all testing of computer applications using the in built testing tool in THINQ Compliance Manager©, automatically capturing results and electronically signing off all records.

see Medical Devices case study