If you think about what it takes to bring a medical device to the market, there are several phases that you go through. Usually, it starts with the project plan that specifies tasks that must be completed to get your product to market. You then develop specifications and make any number of things.
Getting to market also includes being compliant with ISO 13485, which is a global standard for Quality Management System that is voluntary in the US but required in some countries. In the US are most of the requirements similar to the whole world. For example: To comply with the US FDA’s code FDA 21 CFR 820 medical device companies need to establish a CAPA process within their QMS, also covering the design, manufacture, packaging, and labeling, etc. the same as ISO 13485 or 9001.
Keep in mind that quality standards are meant to protect the customer, and since the customer is the reason the business exists, it is the core of the business. If the quality system is helpful to people, then quality professionals also present themselves not as enforcers, but more as support. The idea is to promote effectiveness rather than enforcement.
Tool for easier compliance
The reality of today is you should start with an appropriate QMS software.
Quality management software is a system that should help with the manufacturing company’s control and comply with the most stringent quality standards. Moreover, quality management software offers an extensive suite of tools and capabilities necessary to cost-effectively manage a quality control system that can help.
In case you are looking for the best electronic QMS solution, you are probably wondering what is the difference between all of those QMS software that you might found on the Capterra, or some other website with a focus on aggregating user reviews for business software.
It’s easy to notice the majority is cloud-based which is the best solution and common nowadays.
Plus, make sure to check they are validated — the software system has to meet specifications and that it fulfills its intended purpose.
The one thing you might not think much about is the way the software is structured. But that part is crucial. Some software is project-based, and some are constructed on specific modules. Now you wonder which one is better?
Even though it seems that module-based software can be easier to handle, they are limiting.
What are the differences?
Module-based QMS software usually gives you a certain number of modules that cover almost every aspect of Quality Management. It differs from software to software. There are numerous management module solutions like Risk Management, Customer Management, CAPA, and so on. Each one of them represents separate software components. It separates the functionality of a program into independent, interchangeable modules, such that each contains everything necessary to execute only one aspect of the desired functionality. The limitation part is you are dependent only on those modules that the software provides and it disables the option of combining the two in case you need it or simply work that way. Plus, most of them charge per each module, separately, which is quite frustrating.
Project-based QMS software is quite a different story. They have a process-oriented approach. Such QMS software integrates the various internal processes within the organization and intends to provide a process approach for project execution. A process-based QMS enables the organizations to identify, measure, control, and improve the various core business processes that will ultimately lead to improved business performance. It measures the full set of activities in one business. For instance, it focuses on internal processes such as document management, CAPA, training, customer satisfaction, quality of the product, etc. It sort of represents a network of interrelated and interconnected processes.
Certain project-based eQMSs supports features that accompany your quality management system, without a need to buy a module. By just creating a project and naming it, you have any quality event you need.
Best QMS choice
It’s important to understand every manufacturer is unique and not all users require the same level of quality software sophistication. You need whatever it is required that describes the product that you are bringing to the market. And these specifications require a lot of input from your entire team.
qmsWrapper — Management Through Quality Compliance
Quality shouldn’t be measured by the price tag, since all-in-one, integrated QMS tools offer more than just the sum of their parts, they offer all the same functionality as API combined separate software with the wonderful attribute that they cost much less than the sum of all the separate software packages would be. Go figure! Your budget should be breathing easier already.
qmsWrapper is an all-inclusive, fully integrated Quality Management Software. It includes Project Management, Quality Management, Risk Analysis, Integrated Team Chat, and… a full Document Management and Control functionality that provides full support for document search, including the search for documents related to specific processes, projects, sub-projects, type of documents, etc.
In qmsWrapper, the QMS projects come already with some pre-defined templates, which should be reviewed and adjusted to your company’s needs.
An innovative and novel approach to quality and compliance can best be expressed as management through quality compliance as opposed to quality management. Management through quality compliance is different because the focus is not on quality as the end game, but rather on quality as the process to achieve compliance. Quality compliance is not only the end game, it is also how the game is played.
Fundamentally, management through quality compliance is based on ongoing collaboration between the various team members and management that links each step in the project process.