Case Study: Medical Devices

In 2001 THINQ was engaged as part of a global re-engineering project. The customer had over 50 different and disconnected applications covering all aspects of manufacturing and distribution, quality and service support across more than 20 global sites. Part of the drive for change related to recent FDA audit findings, especially in relation to device manufacturing operations. THINQ compliance experts formed part of the global project team, which at its peak reached over 80 people. Key goals included an integrated Enterprise Resource Planning system from Peoplesoft, a Data Warehouse solution from Informatica, Product Life Cycle management from Agile and iMAN, Shop Floor Control from Datasweep, Barcoding from DSI and new CRM functionality using custom software. The IT infrastructure was based on RS6000/AiX technology using Windows workstations and TekLogix handhelds for field based service personnel.

The project was constructed into four main phases spanning nearly 3 years in implementation and validation. When it was completed it represented the largest validated installation for Peoplesoft (previously JD Edwards EnterpriseOne software) anywhere in the world.

During a 2005 FDA audit at the customer, and after auditing the new computer system for nearly 3 weeks, the FDA found no deficiencies and issued no 483’s.

During the project, which was completed on time and budget THINQ:

Performed vendor audits at all software suppliers and the outsource supplier for the IT infrastructure.
Wrote over 400 documents and versions which were combined into various validation protocols for each of four phases executed at over 20 different sites.
Created a traceability matrix that tracked thousands of requirements, design and configuration documents and tests.
Delivered customized compliance training to over 100 project team members and senior management.
Qualified the IT infrastructure to COBIT standards, writing more than 40 specific Standard Operating procedures.

see Pharmaceutical case study