Frequently Asked Questions
Frequently Asked Questions
Below you will find answers to the questions we get asked most frequently prior to purchase.
GENERAL
HOW MUCH TRAINING WILL I NEED?
Simplicity is at the core of our design to ensure that customers are not overwhelmed when introducing an electronic QMS. Users require as little as 2-3 hours training. The customer on-boarding process may take as little as 2 days. A User manual will be available.
HOW DO I MOVE MY EXISTING QMS CONTROLLED DOCUMENTS AND PROCESSES INTO COMPANIONQMS?
There are several proven methods to accommodate this request. We will discuss your requirements with you as part of our implementation process.
WHAT HAPPENS IF MY COMPANY IS ACQUIRED?
CompanionQMS is designed to facilitate easy export of all documentation, logs and reports. Following termination or expiration of a customer’s subscription for any reason, we will deactivate the customer’s account. Access will be granted for thirty (30) days to retrieve data or request its early destruction. All confidential information will be returned to you or destroyed, at your request.
HOW DOES COMPANIONQMS HELP WITH INDUSTRY SPECIFIC STANDARDS AND REGULATIONS?
CompanionQMS is designed to assist customers meet ISO 13485 and FDA QMSR requirements for quality management systems. CompanionQMS is also designed to assist customers to meet 21 CFR Part 11 requirements for electronic signature requirements.
SALES
HOW MANY USERS CAN I ADD?
The initial standard subscription offers 25 users. Pricing for additional user subscriptions shall be at the then-current user prices, prorated for the remainder of the then-current subscription period.
WHAT HAPPENS IF I DECIDE NOT TO RENEW THE LICENCE?
Notice for termination is agreed in the contract terms with each customer. Customer data will be returned in accordance with agreed terms.
IS THERE A FREE TRIAL?
We can provide a free demo and trial period before purchase. Contact support@companionqms.com
WHAT SUPPORT CAN I EXPECT?
Email Support: Queries are directed to an email account support@companionqms.com during Standard Business Hours. Turnaround Time: We will make reasonable efforts to respond to emails within one (1) Business Day. Free software version upgrades are included during the subscription period.
WHAT IS THE STORAGE ALLOWANCE?
There is a standard allowance of 100GB of storage per customer per three-year term. Additional storage is available, for more details, please contact support@companionqms.com
WHAT IS THE PAYBACK PERIOD?
By simplifying and streamlining processes through automation, an organisation can vastly improve document approval cycle times, reducing the cycle from months to days, or from several weeks to several days. CompanionQMS can reduce typical workflows in any medical technology company by at least 50%. Companies will gain from the redeployment of valuable resources to core value – add activities in product design and manufacturing.
FUNCTIONALITY
HOW DO I ADD A NEW USER?
To add or remove a new user, please send the name, role and email address to support@companionqms.com
HOW DO WE DISTINGUISH BETWEEN PROJECTS ON THE QMS?
Use the DHF (Design History File) column / Label (There are extra DHF labels available). CompanionQMS also supports custom DHF numbering schemes.
HOW LONG ARE RECORDS RETAINED?
Records can be maintained by CompanionQMS for at least seven years, based on customer request.
HOW IS VERSION CONTROL HANDLED?
Version control ensures your team is always working off the most current version of a document. Document versions are controlled using the file name, making documents more directly accessible using the sort and search functions. Filename and document types do not have to be persisted from version to version. New or changed versions of documents are added to CompanionQMS through guided workflows. The workflows also allow you to make existing versions of documents obsolete.