Computer Systems Validation – Key Questions Answered

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?

The answers to these questions are determined by where and how the ERP system is being used within the organisation. Taking the first question for example:

Which parts of the Pharma Value Chain are subject to CSV?

The pharmaceutical value chain may be described as follows:

  • Discovery
  • Pre-clinical development
  • Clinical development
  • Manufacturing
  • Distribution
  • Marketing & Sales.

Where the ERP system is being used to control drugs which are being used in human beings, then the ERP system must be validated. So in relation to the value chain above, the stages of discovery and pre-clinical development do not involve the use of drugs in human beings, therefore the ERP system does not need to be validated. All stages from clinical development onwards do need to be validated. If a single ERP system is being used across the whole value chain within the organisation then it must be validated for all modules which impact on the control of drug related inventory. This leads to the second question.

Which modules of an ERP System need to be validated?

The module combinations vary somewhat from one ERP system to another. However where a module is being used to control drug related inventory then it must be validated. Modules such as inventory control, purchasing, production control, work order management, sales order processing, shipping and quality assurance all fall within this category. This is because all of these modules are involved in the traceability of inventory throughout the full supply chain. On the other hand modules such as finance, master scheduling, capacity planning and materials planning do not need to be validated. This is because these modules are not controlling inventory, they are providing financial control or planning functionality only. So, by answering these two key questions an organisation can quantify its computer systems validation effort and put in place a validation master plan which will ensure complete and effective regulatory compliance.

This blog was written by Frank Crewe, Principal Consultant at Lumenia. If you would like further information on Computer Systems Validation or on any other aspect of ERP please send an e-mail to Frank Crewe.