Lean & Operational Excellence and Independent ERP Consultants

When working with ERP systems in the life sciences sector there are two key questions in relation to computer systems validation (CSV) which clients always ask. Which parts of the pharmaceutical value chain are subject to CSV? Which modules of an ERP system need to be validated?

For regulated industries such as those in the life sciences sector, computer systems need to be validated to prove regulatory compliance. When implementing Enterprise Resource Planning (ERP) systems, companies must make sure that their validation plans form an integral part of the overall implementation project plan.

In recent years we have seen much of the traditional manufacturing industries in Europe relocate to the lower cost economies such as those in Asia. Governments across Europe are looking to the Services sector to replace the jobs which are being lost. Leaders speak of the “Knowledge Economy” or the “Smart Economy” as the way forward. This Opinion considers how service companies can have sophisticated and effective IT systems with affordable total cost of ownership.

Some organisations, when faced with the need to implement new Enterprise Resource Planning (ERP) systems, have to decide between a packaged system and a bespoke development approach. What are the factors in making this decision?