If you are considering an electronic Quality Management System (eQMS) to manage quality events and activities, deciding what is important to your organization will help determine which vendor and system are the right fit. Here are a few things to consider during the selection process.
Defining organizational requirements for eQMS
It is important to determine which quality processes will be managed in the system. Will you only be performing SOP management, or will you also be managing Training, Document Management, CAPAs, and Audits? You may be looking for only training and document management to start out, but then as your business grows, the quality systems should provide the support you need. Planning ahead for all potential needs for the quality solution will help you make the best decision regarding the type of system you need.
Quality Interactions Across the Organization
When implementing a new EQMS, it is important to consider the needs of all departments who will interact with the quality system, in addition to your Quality Assurance Group. Creating a cross-functional team to evaluate needs will provide a constructive opportunity to collect all business unit requirements and input. This can be managed either in-house or by a third party, but having the right people participate in the conversation early before moving forward in vendor selection is very important.
Out-of-the-box pre-configured or customized system
When identifying the type of quality management software that is the best fit for your organization, there are two key elements you should be thinking about; whether or not your existing processes fit into the structure of an out-of-the-box pre-configured system, or whether a customizable system that can be designed to company specifications would work better for your organization.
The results of this type of discussions and requirements analysis will most definitely influence your planned budget. Conversely, your budget may be the deciding factor in the type of system you ultimately select.
eQMS Budget
There are many eQMS vendors out there, so selecting the one that has the right technology that fits into your budget can be daunting. If budgetary restrictions govern the type of EQMS you will select, then an off-the-shelf hosted product might be the most practical option vs implementing an on-premise customizable QMS. Whether it’s off the shelf, cloud-based, data center hosted or an on-premise customized implementation it is important to understand all company requirements and all associated costs. Make sure that you select the optimal system that will meet your current and future needs.
Validation Process
Most good quality management software vendors should provide you with a validation documentation package and templates of the IT SOPs (standard operating procedures) that are required to implement, validate, manage and use the EQMS. Some vendors will charge extra for validation or you will need to hire a third party to perform the validation. This could be a hidden cost that you weren’t expecting or anticipating. Make sure you understand what is required to have your eQMS system validated and what changes, if made to the system, will
In Summary
Ultimately if you are looking for an EQMS solution, make sure to have the right end user representation involved in the selection to ensure a successful system adoption. If you have an internal IT department, ensure they provide input into the evaluation of the type of system you can support in-house, and they may also have previous experience in system selection.
