Will provide global pharmaceutical manufacturers with local access to highly qualified ERP system validation consultants to help ensure regulatory compliance and reduce overall project costs
NEW YORK, NEW YORK (INTERPHEX 2004 CONFERENCE) – March 16, 2004 – Invensys Validation Technologies, a world leader in regulatory compliance, today announced the launch of a global consulting practice focused exclusively on the efficient and cost-effective validation of Enterprise Resource Planning (ERP) systems in the pharmaceutical and other regulated industries.
Headquartered in Toronto, Invensys’ global ERP practice has highly experienced, highly qualified ERP validation consultants based locally in principal pharmaceutical processing regions around the world. These consultants utilize Invensys’ well-proven ERP project management and validation methodologies to ensure consistent implementation practices at pharmaceutical facilities anywhere in the world. Mike Howden has been appointed director of Invensys’ ERP validation practice.
“Not surprisingly, most US FDA validation experts are based right here in North America. As a result, for ERP validation projects outside of North America, specialists often have to be flown in to provide the required expertise,” said Richard Fecteau, vice president and general manager of Invensys Validation Technologies. “To the best of our knowledge, only Invensys Validation Technologies has the critical mass required to staff a global ERP practice. This reduces costs, reduces implementation times, and ensures a consistent approach that is particularly appealing to multinational pharmaceutical companies, many of which we are proud to list as our customers.”
Invensys Validation Technologies has already successfully completed more than 30 validation projects to date on ERP systems from SAP, J.D. Edwards, Marcam, and others.
Specific ERP validation consulting services offered by Invensys’ new global practice include:
•Full ERP System Lifecycle validation
•Implementation/upgrade and enhancement project management
•System Risk Assessments
•21CFR Part 11 compliance services
•IS/IT validation infrastructure assessments and validation support
•Quality assurance system reviews and audits
•Design qualification
•System “go-live” protocols
•Business continuity planning
•ERP data warehousing and archiving validation
For more information, readers can contact Mike Howden in Toronto at +416-953-0343 (mike.howden@invensys.com).
