Main Criteria for Selecting the Right Quality Management Software (QMS)
Are you thinking of investing in a new electronic quality management software (eQMS) for your organization? You have heard so much about how the software can help companies swiftly deliver the best quality products and are interested in it.
Companies should look for an eQMS solution that will provide a rapid return on investment. Most importantly, the solution should be able to effectively align with your business processes, documents and company policies
There are lots of things to take into consideration before selecting QMS vendors because the functionality should not be the only feature to consider in selecting a new solution. There are so many other aspects worth considering flexibility, integration capabilities and implementation, which are listed below for your convenience.
Ease of Use and Flexibility to adapt to business processes: The most important consideration is the ability of the platform should be easily configurable and adapt to your existing business processes and be flexible enough to change and meet the needs of your business, including pharmaceuticals, life sciences, medical devices, biotechnology, chemicals, manufacturing, drug manufacturing and so many more. Find a right software that can configure all the aspects of the tools like creating forms, configuration of workflows, fields, business algorithms and generating the reports. It is important to have an eQMS that is flexible enough to adapt to a changing regulatory environment.
Regulatory Compliance: With ever-evolving regulations, compliance is more complicated than ever. It’s essential for life sciences or drug manufacturing companies to select a quality management software that satisfies regulatory and statutory standards related to a product or service. Of course, it needs to meet customer requirements as well. The eQMS Software should supports many industry standards including FDA 21 CFR Part 11, EU Annex 11, MHRA, GAMP, GMP, and ISO and many more.
Maintain Data Security and Control Access: When looking to select an eQMS system where you are in full control of it. It should have the built in best practices for complete access control and data security. With the help of user based or role based security enables you to make sure that the right personnel will have access to the right information and at the right times. A QMS must be compatible with industry standard security practices, such as a two-step verification process, to safely store confidential information.
Tracking and Reporting: When you are automating your quality management process using a QMS Software, there is a huge amount of data is created. Without an automated system, it is difficult to track and finding the data, filtering the data and producing the quality reports. This is a time consuming effort, laborious task and may require the administrative intervention. When selecting a quality management software solution, check whether it generate different types of reports you need and helping to get the right information to management or stake holders to make a better decision making process to make an proper analysis for the process improvements.
Integration Capabilities : It is important that the system have an integration capabilities into the software that can give your business visibility into other existing systems within the organization whether they are quality systems or production systems, allowing for quicker resolution to the quality related issues and better collaboration between operational department areas. By having the integration options available in the application, this will eliminates the double entry of data, pull the required data from the systems and push data back to these systems.
Implementation: For companies operating in a highly regulated industries, safety comes first. Choose a vendor or partner who has extensive experience helping companies to manage regulatory standards, and a strong implementation record to ensure that complex drug manufacturing environments can be efficiently managed. To be competitive you must meet compliance standards and your product must be of exceptional quality. An electronic quality management solution that is built specifically to cater to your industry may be the best fit.
Learn how to determine the ROI of an eQMS solution or contact us for a demo of our AmpleLogic Electronic Quality Management Software today.