If you speak to any CSV or software validation expert about any complex projects that they have been involved in, a wide variety of different challenges may emerge. From dealing with unverified third party data to building graphics screens that represent a particular process stream, different challenges need to be overcome in order to provide fully compliant and dynamic computerized systems.
One of the most common projects that involves the widest range of issues to overcome can be the installation of an ERP system across a manufacturing site. In this blog, we’ll discuss different challenges that can arise and how to overcome them.
Selecting the right ERP software vendor
Let’s be honest, this is probably the most important decision to make. Each individual stakeholder will have different selection criteria – finance will want the most cost effective system, IT will want the most user friendly option and engineering will want the package with the widest range of uses. It’s important to base your decision on not what the cheapest option is – aim for one that keeps all stakeholders happy.
Risk assessment & risk based decisions
From a validation and business perspective, performing a correct risk assessment on all aspects of the URS is critical. This will help set out the exact levels of validation required. During planning, a risk assessment will determine what testing approach can be taken and risk based decisions during this phase can reduce a lot of duplicate testing. It is possible that the same software would be tested in integration testing, FAT, SAT, IQ/OQ/PQ, so cutting down on un-necessary testing will reduce the overall project costs.
Because of the variety of functions that ERP systems provide, an installation project requires the support of a wide number of departments in order to achieve success. To help this implementation, allocating specific timelines to particular tasks and involving each department will encourage a spirit of togetherness and provide full visibility on how the project is progressing.
Correct and prevent
ERP implementation can be extremely complex and pose challenges to all aspects of an organization-during testing, pre-go live and when in full operation. It’s inevitable that there will be setbacks – key personnel may leave, taking with them expert knowledge, there could be budget cuts which could curtail or postpone essential activities. Any organization should use the downtime to address the reason for the setback and plan against future occurrences – prevention is better than cure.
So, to summarise, when implementing an ERP system, it’s important to base a solution not on cost but on the software that best suits all stakeholders’ interests. An organization should make risk based decisions on validation, look for multi department co-operation and use setbacks or delays as a mean of continuous improvement.
Author: Damien Hanley