Features that will help you with
your Design History File (DHF) and
your Technical File (TF)
Traceability Matrix (TM)
The foundation of your FDA Design History File (DHF)
and your CE Mark Technical File (TF).
OrganizeOrganize Your FDA or CE submissions. Every input in the qmsWrapper Traceability Matrix is organized and shows the details, revisions, history and mapped out relations, from the very beginning of the project.
TraceTransparent file tracking - trace requirements through the different stages and show they had been successfully addressed. Keeps track on implemented changes and gives you better understanding of what kind of changes are needed.
ConnectConnect the dots & docs… Requirements are connected to design specifications, to risk analysis, SOPs, test cases, Validation, OPS requirements, to custom column, etc…
ManageGet full control of your project! All your CE Technical Files inputs and your FDA Design History inputs, are connected to project tasks, making it easy to complete, easy to update.
Risk Management (RM)
The Risk Management Module of qmsWrapper includes 5 Steps.
Step 1.Initial Risk Analysis (IRA). This step has 3 main elements, and in this phase can be linked to specific requirements. In Accordance With paragraph 4.2, 4.3, and 4.4 of ISO 14971, you will define the use context of this design requirement, its potential to create a hazard and estimate the risk.
Step 4.Risk Control (RC). When the potential for harm is present, then Risk Control is necessary to eliminate or mitigate the risks associated with the hazard.
Step 2.Hazard Analysis (HA). This is right out of the standard for hazard analysis. It allows you to analyze each requirement that have the potential to be a hazard or contribute to a hazardous situation.
Step 5.Benefit/Risk Analysis (BRA). (HA). If after everything was done for RC and a residual risk remains, MDD/MDR and FDA require a Benefit/Risk Analysis or BRA. A BRA should verify that the residual risk is acceptable to the manufacture, and whether the patient will understand it and accept it.
Step 3.Risk Evaluation (RE).In this Step, you evaluate the nature of the risk, determine the cause of the Hazard or failure and its effect.
Document Management and Control
User-friendly and team focused Document Management System that works for you, not you for it!
- Audit trail
- Change control
- Security file locking
Cloud Access - from any device, any time
- easy and accessible
- on demand scalability
- secure and fast access
Document Approval WorkflowsSimplify feedback and approval cycles without leaving your platform. Workflows are documented through reports, with full approval history. No confusion, re-work or delays.
Electronic trail and Document ControlTrack, store and control documents to prove compliance
PIN Signature (ERES)Secure and Unique Electronic Document Signatures. Reduce risks, simplify compliance and speed up audits by using ERES and not wasting time on chasing people for signatures.
QMS Processes Driven Project ManagementCreate a full circle of follow-up and coordination for each quality objective, task and issue by driving your Projects through QMS Processes.
QMS Workflow ProcessesReduce errors, forgotten paperwork and missed QMS reports through workflow processes that are not leaving any room for guessing what’s next, steps are defined, monitored and managed by management automatically.
Versioning, Milestones, Roadmaps and Gantt charts to help you see the big picture and understand the project status.
Organize workflows, schedule releases and track which issues relate to different releases of the product.
With the built-in qmsWrapper Workflow Process Editor, you have the freedom to build your own Workflow processes.
“My Team” function shows percentage done, reports and assignments.
The Project Management Module is directly connected to the Risk Management Module to ensure ISO and FDA compliance.
Pick somebody’s brain or get fast answers from a particular colleague in a private 1-1 chat conversation.
Connect your teams and accomplish complex tasks through a campfire, group chats.
Meetings Management - schedule, assign and track.
Every message is archived in the history, files shared or sent in chat are automatically stored in the Central Storage and can be linked to any particular project.