e QMS ?
What is an eQMS?
An eQMS (or Electronic Quality Management System) is like a binder containing all your required documents: Quality Manual, Procedures, Work Instructions, Forms and Records.
The collection of your Quality Documents is your QMS (Quality Management System). When this system is electronic, it's called an eQMS.
myQualityCloud is an eQMS, built on Google Drive, the internet's most popular and powerful document management system.
The advantage of an eQMS like myQualityCloud, over a traditional QMS, is that you're getting the advantages of the internet:
Access - See your documents anywhere / anytime.
Links - Everything is connected - this means it's 10X - 100X faster and 90% cheaper to maintain.
Search - The power of Google Search - your company can save thousands of hours not searching paper records.
Quality Policy ?
What is the Quality Policy of myQualityCloud?
KISS or “Keep it Simple, Silly!"
At myQualityCloud we believe in making things fast and easy. To do that, it's important to keep everything simple.
Can I use my own Quality Documents? Or do I need to use specific documents, forms or records?
You can do whatever you want!
Bring your own, use ours, or a bit of both.
If you want to bring your existing documents, it's easy, and we'll help.
If you want to add a document, but don't have it yet we can give you one of ours, we have most documents required for all standards and can develop others for you as part of your basic subscription.
Where do I access my documents?
On the internet.
Anywhere, anytime, you have access to your documents.
Anywhere there is an internet connection, you have access to your documents. You can even keep and edit them offline, uploading changes when you're back online.
But is it secure?
Yes. We use Google Authentication, a very secure user name & password identity verification system.
Can I increase the security for access?
Yes, security can be increased with 2FA (two factor authentication). 2FA increases security by requiring a phone or smart device in combination with username & password to access files.
Who can access my documents?
Only the users to whom you grant access.
What if I want to remove their access?
Yes, changing access to documents is easy.
What if I only want certain people to see a document, and different people to edit it?
Yes, you have full control over your documents.
Have questions? Just ask, we're here to help! We're happy to show you how everything works.
Audit View ?
Is there a way to limit Auditors to just the information they need during an audit?
Yes. Specifically the FDA allows businesses to keep certain data secret (aka, "proprietary") There are 4 types of data a business can keep secret, they are:
- Supplier assessments
- Internal audits
- Management reviews
This is an optional service, available as an add-on to our normal subscription.
How is this different ?
What makes mQC different than those ERP modules from huge ERP companies?
You Matter. We care.
We pay attention to you; you aren’t a number, you're a person, and we care about giving you a good experience.
- Your company doesn’t have to shut down to implement this system.
- You go live on day 1 with myQualityCloud. Unlike ERPs where it's normal to launch 2 years after the contract is signed with a massive go live party followed by 6 months of debugging. .
We're there for you when things change
When statutes & standards change we let you know and offer to adapt your procedures and record forms ASAP!
It's not a module
You aren't getting a module; You are getting an independent and compete eQMS.
Roomfuls of programmers don't have to reside on your site.
This system is tailor fit to your exact needs and is not you shoehorning into an inflexible canned package with features you don’t need.
Part 11. But really.
Now this is a secret: Those other ERPs are probably not really part 11 compliant when you look closely. myQualityCloud is.
myQualityCloud is suitable for companies of every size. From teams of 1 to 1,000,000.
No massive relicensing fee will ever be charged. Your price is safeguarded for the life of your subscription.
How long does it take to get my QMS up and running with myQualityCloud?
You can go live with your top priority documents on day one.
Do I need to setup the whole QMS before going live or can I start one document at a time?
You can start with one document at a time if you prefer, or setup the whole QMS, it's your choice.
Want to start with Receiving Inspection records? Need Design Controls ASAP? Your myQualityCloud helper will get you started right away.
What do i get ?
Companies with an existing QMS
We help ease the transitions from a paper based QMS or other eQMS.
- Go online
- We help bring your existing QMS into the cloud.
- Have existing Procedures & Forms? We'll help you upload them.
- Link important documents (Procedures, Training, Forms, Statutes, Records, etc.) to get up to a 10X improvement in staff efficiency.
- Access anywhere / anytime.
- Multiple levels of security. 2FA optional.
- Total control of documents: limit access, edit, view, comment rights and more.
- Training & Support
- The system is easy to use and self explanatory. But if it's helpful offer training to help your team onboard smoothly.
- Have a question? Just ask, support is included.
- New Procedures & Forms?
- You can use our library of free forms included in your subscription.
- Want to customize something? We can help
New companies that need a QMS - Startups
What if I am start up? You get everything existing companies get, and we'll give you a little extra help to get you on your way.
- Changing statutes and standards
- New Requirements
- Automated Workflow
- Records & Snapshots
- We teach beginners why and how to keep “objective evidence” of compliance.
Document changes ?
Can we update documents ourselves?
Yes! You can independently make changes to documents. If you'd like help or training, just ask, support is included in your subscription.
For small companies we recommend using a simple process called IQ (Installation Qualification). We'll show you how this works when setting up your system. This is required for some standards, including: ISO 9001, ISO 13485, FDA CFR.
For larger companies we offer a more robust Document Control option which includes IQ plus:
- Realtime Team Collaboration
- Signature Routing
- Digital Signatures
- Automated Training
Google business account ?
Why is a Google Business Account included with a myQualityCloud subscription?
myQualityCloud is built on Google Drive, the Internet's most Popular & Powerful Document Management System.
With a Google Business Account you get the full power of Google's Document Management System, which gives your team the security, reliability, and features Google's team of Drive Engineers have developed over the past 10 years.
Are my documents compatible ?
Is Google Docs compatible with my word processed documents?
Yes, 95% of documents and spreadsheets translate exactly to Google's docs and sheets formats. 5% of the time minor tweaking is needed, we can help. Your users will be already comfortable with Google Docs and Google Sheets
What if I Want to leave ?
Your files will always belong to you. You are free to backup or move any of the documents you've uploaded, altered, or created while subscribed to myQualityCloud.
what are the Steps ?
What are the steps from start to go live of my eQMS with myQualityCloud?
- Understand - We start by understanding your business & QMS needs.
- Plan - We prioritize your documents and bring your eQMS online.
- Approval & Training - Once you approve documents your team will be trained via an Installation Qualification (IQ)
- Document Control - documents are controlled after training is completed.
- Audit - You have the option to be audited by myQualityCloud to confirm CFR Part 11 Compliance.