There are benefits to applying an eQMS at the earliest possible opportunity for any medical device company. It is best practice to implement document control from the beginning, and as CompanionQMS provides enterprise-grade content management, your documents will be easily accessible by geographically dispersed teams. The flexibility of CompanionQMS is such that you can partially implement your QMS at the beginning and extend it at an appropriate time for you.

Simplicity is at the core of our design to ensure that customers are not overwhelmed when introducing an electronic QMS. Our clients require approximately a half-day training. The on-boarding process typically takes 5 days depending on user requirements. User manuals and online training materials will be made available.

There are several proven methods to accommodate this request. We will discuss your requirements with you as part of our implementation process.

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.

CompanionQMS is designed to assist customers meet ISO 13485 and 21 CFR 820 requirements for quality management systems. CompanionQMS is also designed to assist customers meet 21 CFR Part 11 requirements for electronic signature requirements.

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.

We understand all businesses are unique and so offer customisation services, enabling you to capture the information you require. For further details contact us at support@companionqms.com

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

We require 30 days of notice for termination of the contract.

Pricing for additional user subscriptions shall be at the then-current user prices, prorated for the remainder of the then-current subscription 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.

We will provide a demo before purchase. Once you have purchased companionqms.com, you can access the system and test the features and functionality. Once you are ready to start using it, we will clear the test files, and you can start afresh.

Microsoft Azure hosts our software, 95% of Fortune 500 companies trust their business on the Microsoft cloud. Azure complies with ISO 27001 for Information Security Management. Whether related to identity management, data confidentiality, or document integrity, we employ industry-standard security practices to protect your documents, data, and personal information.
For additional information about our security practices, please review a copy of our Data Protection Policy, which is signed by both parties before accessing your account Q-Pathway – Sample Data Protection Agreement

Q-Pathway stores all data, including backups in Microsoft Azure storage in European data centres. For durability at run-time CompanionQMS servers utilise locally redundant storage. All personal data is persisted in a database to geographically redundant storage. Also, the entire CompanionQMS infrastructure is backed up daily to geographically redundant storage. For additional information about our security practices, please review a copy of our Data Protection Policy, which is signed by both parties before accessing your account Q-Pathway – Sample Data Protection Agreement

We carry out Installation and Operational Qualification elements of validation and certify this to the customers. CompanionQMS will support you in performing Performance Qualification.

It is an FDA term that means a company is responsible for having a closed system. We do this for customers by providing dedicated servers and administrating on their behalf.
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

To add or remove a new user, please send the name, role and email address to support@companionqms.com

Use the DHF (Design History File) column / Label (There are extra DHF labels available). CompanionQMS also supports custom DHF numbering schemes.

Records can be maintained by CompanionQMS for at least seven years, based on customer request.

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.

Activity Monitoring: The activity graphs highlight at a glance which workflows consume most resources. Events: A calendar and task list provide a means of monitoring time-based quality tasks.

CompanionQMS is compatible with most major internet browsers. Google Chrome version 70 (or greater) and Microsoft Edge version 42 (or greater) are fully supported. Minimum hardware requirements for the browser must be adhered to.