hen adding an electronic quality management system (eQMS) to manage quality activities, there are a few points to consider to ensure you select a vendor and system that best meet the needs of your organization. Here are some must-ask questions before selecting your electronic quality management system.
Question #1 - Who will need to interact with your quality system?
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. Putting together a cross functional team to determine and discuss your needs will provide a constructive forum to gather all departmental requirements and input. Whether assisted by a third party or managed in-house, bringing the right people into the conversation before moving forward in selecting a system and vendor is key.
Question #2 - What quality activities will be managed in the electronic system?
As part of defining your requirements for the new 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 Incidents,, CAPA’s, and Audits? Planning ahead for all potential needs for the quality solution will help you make the best decision regarding the type of system you need.
Question #3 - Do you need a customizable system or would an out-of-the box pre-configured system work for you?
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.
Question #4 - What is our budget for the eQMS?
As with most budgetary evaluations there are multiple factors to take into account. 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 true needs vs. selecting what may appear to be the least expensive option that may not provide what is needed long term.
Question #5 - Do we have the required procedural controls and validation ability to deploy and manage an eQMS?
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. However, it is valuable to have in-house validation expertise that can help with the process. Alongside your validation effort, you also need to be able to put the relevant SOP’s in place, if the vendor doesn’t provide them.
If you are currently managing on-premise regulated computerized systems, make sure your existing procedures address any specific or new technology requirements of the potential quality solution (i.e. backup requirements, system administration and maintenance needs, 21 CRF Part 11 requirements, etc.). Here’s a list of some of the essential IT SOPs that you should have in place for on-premise system.
Ultimately If you are looking for an eQMS solution, make sure to have the right end users representative involved in the selection so to ensure a successful system adoption. If you have an internal IT department, they can provide input into the evaluation of the type of system you can support in-house, and may also have valuable past experience in system selection.
It can also sometimes be helpful to get guidance from external consultants who can work with you to selecting a solution. However, be mindful that the consultant you work with should be able to help you both from a technological standpoint, as well as from a business process standpoint.
Feel free to post your comments below, we love to hear your feedback!