Knowing which QMS type is best for you is very important, considering that a sound QMS is mandatory for all drug and medical device developers. Their utility for record keeping, progress tracking, and risk mitigation make QMS the foundation for any product's successful journey to market!
Can't watch right now and rather read a quick summary? Here is a recap of what Grace shares in the video:
Hello. Grace here from the team at Proxima Clinical Research.
Today we're addressing an important question that's typically asked early in the product development process: should I build a paper QMS or an electronic one? To answer this, let's first make sure we understand what a QMS is.
A quality management system, or QMS is a comprehensive set of production related policies, processes and record-keeping tools that are put in place to address and prevent issues with your product.
Implementing a QMS is required for all regulated sectors and medtech and biotech as it ensures that your product meets the standards outlined in the Code of Federal Regulations or CFR.
Paper based quality management systems require documents and wet signatures. Storage solutions like fireproof or water resistant filing cabinets are necessary for physical record keeping along with secure rooms for document protection.
Paper based quality management systems can utilize electronic signature tools, but it's important that this method is compliant with the 21 CFR Part 11 standard and validated before use. On the other hand, electronic QMS or eQMS is a method that has become very common due to recent technological advances. General ease of use and their capability for effective document management. Advantages of eQMS include easier change control processes, high level overview of all documents, and the ability to track progress.
Electronic systems allow for documents to be easily accessed and maintained in comparison to a paper based system.
eQMS tend to be more costly. However, as companies grow and embrace remote and distributed workforces, the scalability and efficiency of an eQMS often prove more cost effective in the long run.
Generally speaking, an eQMS is the preferable option. By automating workflows, reducing errors and keeping your documentation in one central location, it ensures ease of access and efficient collaboration among team members.
Ultimately, which route you take is dependent on your unique needs and circumstances. At Proxima, we offer expertise in both approaches, and we're here to support you every step of the way.
Reach out to us at proximacro.com where one of our experienced quality consultants will be happy to assist you.