A Quality Managment System is designed to tremendously help your organization achieve organizational transparency and efficency. But for that to happen you still need to choose the right system for your company.
A QMS – short for Quality Management System – is a software (usually either web-based or web-enabled) providing a collaborative platform in order to helps highly regulated organizations automate and streamline their business processes focused on quality management and control for increased efficiency and regulatory compliance.
Indeed, organizations in highly regulated industries have to face the challenges of maintaining a high quality level and of complying with the industry’s specific regulations and policies, all the while keeping up a high level of operational transparency and effectiveness.
In this article we will provide the list of criteria you should consider in order to choose the right QMS for your organization.
THE QMS CHECKLIST:
Before making up your mind about a QMS, it is highly recommended to check on the system’s flexibility and integration options with the back-end systems and general IT infrastructure of your company. An efficient QMS requires its seamless integration into the organization’s pre-existing systems. It should integrate the data enclosed in these systems and ultimately connect them for the sake of creating smooth and intelligent information flows across your organization’s various systems, facilities, databases, devices and departments. Not doing so expose you to a chaos in which content and sensitive documents are being scattered all over your organization, making it highly difficult to localize and manage.
Security and Monitoring
A great QMS should include high security standards, such as configuration of users’ rights with permission levels based on the users’ credential, and forgery-proof digital or electronic signatures.
Audit capabilities are also an important requirement for your organization to ensure complete transparency of its activities; and tools such as audit trail, document history, and workflow reports are absolutely necessary. Not only do they ensure you are compliant and auditable at any time, but they also empower your workers with a better understanding and insight of the data, thus enabling them to make greater strategic decisions.
Customization and Scalability
Be certain to verify that the QMS you are offered is configurable and customizable to fit your specific needs and requirements, and with a user interface easy enough that you do not have to do extensive development yourself.
Keep also in mind that your organization might very well grow in size, and that the QMS you are going for is scalable to your needs. For instance, it should be able to be spread over several sites if you have multiple facilities, and should be able to handle the addition of new users without a hitch.
Vendor’s strength and innovation potential
Evaluating the vendor is as much – if not more – important as evaluating the QMS solution itself. The vendor should be understanding of your business needs, offer support services, and have an experienced staff ready to guide you all through the process of implementing and deploying your QMS.
Give credit to vendors who are aware and keeping up with upcoming technologies (mobile, cloud, etc) and are committed to keep their solutions at the forefront of the industry.
Certification & Regulatory Bodies
The QMS system you are implementing needs to have expertise with the regulations you have to follow.
Always verify the list of regulatory bodies and certifications the system cover, whether ISO 9001: 2008 (standard for the quality management of businesses), ISO 13485 (QMS certification for medical devices) FDA (Food and Drug Administration), Current Good Manufacturing Practices (cGMP), Current Good Laboratory Practices (cGLP), to cite only a few.
Finally and obviously, take the time to get a full view of the system capabilities and features. Make sure that the system can properly manage, automate and streamline your business processes.
An optimal QMS should generally offer the following features:
- Automated workflows to manage your SOPs: for instance check if they offer CAPAs, Standard Doc Approval, Change Control automation, etc., as well as workflow customization
- Advanced versioning: to find the latest version, retrieve the earlier versions, compare versions and maintain documents over their complete lifecycle
- Training records & services: to ensure that records of the training are being maintained, and that the employees are fully competent at using the QMS
- Digital signatures: to ensure security and legality throughout the quality processes
- Reporting and Audit trail: to keep track of all the actions taken, actors involved and time stamps, in order to be auditable at any time.
- Document Lifecycle Management: with capacities such as automatic document retention, storage, and classification
Once that check list is completed, you have all the cards in hand to choose wisely the Quality Management System that will fit your organization, streamline your processes and help you achieve regulatory compliance.