eQMS Innovation
If your organization has an ISO13485, QMS MDR 2017/745, 21CR820, ISO9001, ISO27001, MDSAP, quality management system, you can leverage Confluence®to meet many of the requirements of these standards. Our eQMS solution is configured using top-tier applications from Appfire, QC Analytics PC, and SoftComply. These industry-leading tools ensure a robust and efficient quality management system tailored to meet ISO 13485 standards. Build your own workflow modules based on below details:
Efficient Solutions
Empower your team with innovative tools designed to streamline operations and enhance productivity. Our services are tailored to meet your unique business needs.
Simplified Management
Use our pre-configured solutions built on industry-standard platforms to support organized, efficient, and collaborative project management
Enhanced Performance
Enhance team performance using configurable, industry-standard platforms. Improve efficiency, support consistent outcomes, and enable effective collaboration.
Seamless Integration
Implement our configurable tools within your existing workflows to support a seamless transition and enhance process efficiency.
Streamlined Solutions Inspired by Atlassian
Document Control
Automated workflow for authoring, review and approve SOPs, Policies , Design reviews, and Product Technical file documentation. Receive notifications automatically.
We help you create customized approval processes that meet your team's unique needs.
Add Document Version Numbers, Version Notes and Document Approval History with e-signatures.
Publish approved content, and Users can confirm they have read & understood authorised pages.
Convert a single Confluence® pages or entire page tree hierarchies from your Confluence® spaces to PDF format at the click of a button – all with full control over the look and feel.
Change Management
Automated workflow for authoring, review and approve Document or Product Change Requests.
We help you create customized change approval processes that meet your team's unique needs, using your own Change request approval forms.
Add links or attachments of the significant medical device change assessments, direct and easy links to your SOPs, Work Instructions, Policies changes created in Confluence® as part of the QMS system.
Capture the approval with an e-signature.
CAPA Management
Automated workflow for authoring, review and approve Corrective and Preventive actions (CAPA) Requests.
We help you create customized CAPA approval processes that meet your team's unique needs, using your own CAPA request approval forms.
Add links to your Jira® , CAPA Risk Management, Change Orders records documentation.
Add attachments to your records implementation.
Capture the approval with an e-signature.
Internal Audit Management
Automated workflow for authoring, review and approve Internal audit schedule and reports.
We help you create customized internal audit approval processes that meet your team's unique needs, using your own Change request approval forms.
Add links to your non conformities created in Confluence® .
Capture the approval with an e-signature.
QMS User Training
Automated workflow for training assignments to relevant employees when SOPs ,Policies and Work Instructions updated.
Users can confirm they have read & understood authorised SOPs ,Policies and Work Instructions. See who reviewed the current version of a SOPs ,Policies and Work Instructions, who is still on pending and who need to review it again. Send email notifications about pending review.
Display a user’s or a user group’s that reviewed a particular SOP, Work Instruction, Policy.
Capture the approval with an e-signature.
ISO13485/21CFR820 templates package
As part of the implementation we offer you our free templates of the ISO13485/21CFR 820 Procedures, Quality Manual, Forms.
You will be able also to import all your own exiting documents into the eQMS innovation system.
Risk Management (ISO14971) templates package
As part of the implementation we offer you our free templates of the ISO14971 Procedures, Plans, Reports.
You will be able also to import all your own exiting documents into the eQMS innovation system.
Technical Documentation for Medical Devices
Automated workflow for authoring, review and approve Product Technical file documentation. Receive notifications automatically.
We help you create customized approval processes that meet your team's unique needs.
Add Document Version Numbers, Version Notes and Document Approval History with e-signatures.
From product requirements to product plans, we’ve got a template that’s a perfect fit for your project.
Use a single space for all your documentation (plans, product roadmaps, drawings, reports, design reviews, CER, CEP).
Issue up-to-date release documents before the product go live.
Create and manage in the same QMS Space, as many Products File documentation as you need.
Maintain and track all your Product versions.
Distinguish between different products, country registrations and versions.
Supplier Management
Automated workflow for authoring, review and approve your company Suppliers.
We help you create customized supplier approval processes that meet your team's unique needs, using your own supplier request approval forms.
Add links or attachments of Supplier Risk Management, Supplier Corrective action forms, Supplier evaluation records documentation (ISO Certificates, Data protection assessments, Cybersecurity assessments, terms and conditions, Invoice, PO) .
Capture the approval with an e-signature.
Non Conforming Product Management
Automated workflow for the identification, documentation, evaluation, investigation , segregation, disposition (scrap, return to supplier, downgrade, rework, Use As Is, Concession) and approval with esignatures of the Non Conforming Product (NCR) Requests.
We help you create customized your NCR approval processes that meet your team's unique needs, using your own NCR request, Concession approval forms.
Add links to your received components/material that fail incoming inspection , products with defects, NCR Risk Management, Change Orders records documentation, Concession approval.
Add attachments to your records implementation.
Capture allthe approval with an e-signature.
Software Requirements and Test Management for IEC 62304 compliance
Automated workflow for authoring, review and approve SAMD (software as amedical device) Product Technical file documentation. Receive notifications automatically.
We help you create customized approval processes that meet your team's unique needs.
Add Document Version Numbers, Version Notes and Document Approval History with e-signatures.
From product requirements to product plans, we’ve got a template that’s a perfect fit for your project.
Use a single space for all your documentation (plans, product roadmaps, drawings, reports, design reviews, software development plans, Software requirement specification (SRS), Software architecture design (SAD), User needs, test plans, test reports, Validation plans, Validation reports, Usability Plans and reports, Risk plans and reports, Hazard log, CER, CEP, PMCF, GSPR, declaration of conformity ).
Issue up-to-date release documents before the product go live.
Create and manage in the same QMS Space, as many Products File documentation as you need.
Maintain and track all your Product versions (STED).
Distinguish between different products, country registrations and versions.
Complaints Management
Automated workflow for authoring, review and approve Complaints. Log all the feedback.
We help you create customized complaints approval processes that meet your team's unique needs, using your own complaints request approval forms.
Add links to your nonconformities, CAPAs, Field safety notices, Regulatory assessments created in Confluence®.
Capture the approval with an e-signature.
SAMD (IEC62304/IEC 62366-1) templates package
As part of the implementation we offer you our free templates of the IEC62304/IEC 62366-1 Procedures, Forms.
You will be able also to import all your own exiting documents into the eQMS innovation system.