QMS for Beginners – A quick guide on where to Start ! …Part 3

The 13 items that will guide you through the implementation of QMS ...Let's pick up where we left off !

8. Selecting the right system to support your Compliance

Compliance Solutions are essentially QMS based solutions. They come in all shapes and sizes. Some solutions, such as ZenQMS are nothing more than forms tacked on to a project management workflow. They are missing many of the Compliance elements of a complete QMS system.

Most QMS systems are big enterprise level systems. Examples include MasterControl, Viva and ETQ. Sometimes they provide scaled down versions but the usual suspects usually remain expensive and just as difficult to manage as the enterprise systems they are based on. They are scaled down systems that are meant to not be too good, so they can protect the pricing of the Enterprise Systems.  

A Startup has to include various QMS functionalities to properly support Compliance but do it in a way they can handle – i.e. within the context of their personnel limitations and knowledge. Rarely are there more than only 1 x QMS manager in a startup or even a medium sized company (to find QMS managers you usually look in the basement office, a forgotten closet…).

What to do?
Don’t be fooled by scaled down systems. They rarely inherit the good genes of their Enterprise systems. Rather focus on solutions designed for Startups and Small and Medium Sized Company’s. Like in golf, know your handicap.

9. Web based – it’s really an HR issue!

The next issue, is whether you have the human resources to support an in-house network. Stop thinking this is even a possibility. Todays, web-based options move network management to the web application provider. The reality is that you simply don’t have the manpower or technical expertise to setup and manage an internal network. Instead, go with a web-based solution and invest in a better internet connection instead – its far cheaper, but more importantly, keeps your team focused on their essential tasks.

10. Team communications – how will you communicate with each other?

Right now you’re asking yourself why is team communication important when the issue is a QMS system for Compliance.

Simple, Team messaging is the best and easiest way for teams to communicate, and although there are many Team messaging apps on the market, none are purpose built to help your team support Compliance -- except one.

The problem with the “any” Team Messaging apps, such as Slack™, Hip Chat™, Skype™, Facebook Workplace is that chat messages and files shared via chat are lost to compliance. Sure, some of them have a Bot function you can program and hope it catches everything, but that’s time-consuming and more work again. Argh, another job.

But the real culprit is that most of those apps are really meant to include the Social in the workplace, especially Facebook™ and Skype™. Preach as they might, these apps want users to have their social and work contacts together. Can you say, not working on priorities? Can you say, Security Back-door?
Keep the team focused -- on work!

Email? Not for internal communications! Chat is faster and far more efficient. Users get to the point immediately. There’s no ping pong. And much like any 3rd party chat app, compliance documents stored in emails are also lost to document management and compliance. Email routing or sorting is not the same. Use Email for communicating with the outside. Use Chat for the Team inside.

qmsWrapper chat is Team based compliance:

• Purpose built to support compliance
• Files shared via chat can be connected directly to Projects
• There is no loosing focus from external social media distractions
• No more time wasting on email ping-pong

What more do you want!

11. Validate the QMS system before you use it

Before you can use a QMS system, both FDA QSR’s require that you validate your QMS system for “Intended Use” and ISO 13485 requires validation “For Use”. They are very similar and differ essentially in level of testing.  

What is critical for you however, is that your validation efforts must be documented, even if the “off-the-shelf” application does not belong to you. This means creating your own requirements, specifications, validation documentation, which will steal valuable time from your team, from your product development.

"What is critical for you however, is that your validation efforts must be documented, even if the “off-the-shelf” application does not belong to you."

qmsWrapper can offer you an up to date and full set of QMS compliance documentation so you can prove compliance for either FDA’s Validation for Intended Use or ISO’s Validation for Use. 

This complete set of FDA and ISO compliance documentation represents an estimated 423 hours of your team’s valuable time saved, and this for each software update so your compliance requirements are always current.

QMS for Beginners – A quick guide on where to Start ! …Part 1

QMS for Beginners – A quick guide on where to Start ! …Part 2

QMS for Beginners – A quick guide on where to Start ! …Part 4