What the hell is eQMS software and why would any sane company need it?
Glad you asked. The short answer is that indeed no company needs it.
The long answer is that it's about increasing efficiency and reducing risk. For example, you're probably using some sort of software to manage your tickets or user stories for your product, e.g. Jira (ugh), Notion, Linear, etc. Technically, you don't need that - you could just manage your user stories in a Word document and send that around via email. But that would end up being an epic mess and extremely inefficient.
Likewise, you could just use Google Drive for your medical device compliance documentation and that would work, too. I've seen companies pass audits with this approach. However, that also ends up being an epic mess and extremely inefficient. Instead, if you use eQMS software, your documentation gets structured in a much better way - your design inputs, system tests, documents, records, incidents, and CAPAs are all stored in a structured way - just like Linear stores your user stories in a structured way, too.
That enables you to create your documentation in a very efficient way. And I haven't even started talking about Formwork AI features yet, which enable you to use LLM integrations to automatically draft and change your documentation, thereby saving you lots of hours of manual work!
And it's about reducing risk, too - because getting your manual clunky Google Drive or Jyra setup certified is entirely possible, but you'll have a lot of explaining to do towards your auditor. And as auditors are generally technically not very competent, they might have many questions. Instead, if you use an eQMS software which has passed many audits already, your chances are higher to pass your audit, too.
So let's get started!
Glad you asked. The short answer is that indeed no company needs it.
The long answer is that it's about increasing efficiency and reducing risk. For example, you're probably using some sort of software to manage your tickets or user stories for your product, e.g. Jira (ugh), Notion, Linear, etc. Technically, you don't need that - you could just manage your user stories in a Word document and send that around via email. But that would end up being an epic mess and extremely inefficient.
Likewise, you could just use Google Drive for your medical device compliance documentation and that would work, too. I've seen companies pass audits with this approach. However, that also ends up being an epic mess and extremely inefficient. Instead, if you use eQMS software, your documentation gets structured in a much better way - your design inputs, system tests, documents, records, incidents, and CAPAs are all stored in a structured way - just like Linear stores your user stories in a structured way, too.
That enables you to create your documentation in a very efficient way. And I haven't even started talking about Formwork AI features yet, which enable you to use LLM integrations to automatically draft and change your documentation, thereby saving you lots of hours of manual work!
And it's about reducing risk, too - because getting your manual clunky Google Drive or Jyra setup certified is entirely possible, but you'll have a lot of explaining to do towards your auditor. And as auditors are generally technically not very competent, they might have many questions. Instead, if you use an eQMS software which has passed many audits already, your chances are higher to pass your audit, too.
So let's get started!