Get your medical device through
Traceability Matrix (TM)
FDA 510k class I, II, De Novo & CE Mark Class 1, 2a & 2b Compliance Starts with the TM
Seriously Organized Audit DocumentationEasily build a seriously organized traceability matrix for your 510k or CE mark application. This is the cornerstone to all your DHF and CE technical files. Auditors appreciate it, but you will love it!
Transparent File TrackingRelate requirements to testing, to risk, to whatever you can customize. Drop in a form, capture the data, clone them if needed, all files can be linked to project tasks for transparent tracking.
Integrated To Your ProjectsDon’t have to hunt for file origins! 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.
Custom TM ColumnsCreate your own TM structure with a flexible system designed to satisfy the standards, or company specific requirements.
One Unique ID to Connect Them AllConnect the dots & docs… requirements are connected to design specifications, to risk analysis, to SOPs, to test cases, to Validation, to OPS requirements, to custom column, etc…
Details, Revisions, Relations & HistoryGet full control of your TM! Every file in the Matrix is organized and stored with details, revisions, full history and mapped out relations, in custom data entry Forms.
Custom FormsHundreds of Customs forms already included that meet ISO and FDA requirements. Easy to enter data forms Default Technical Requirement Forms Add your own forms to any project or task Simple, fast, efficient, flexible!
Custom Form EditorNeed something unique, customize one, it’s super easy! Create any form Attach it to any issue Create the form you need in the project you need it.
Forms and Form Editor
- Easy to enter data forms
- Default Technical Requirements Forms
- Get the right data in the right format.
Drag & Drop Form Editor
- Need something unique, customize on, it’s super easy!
- Create any form with a flexible drag & drop platform
Add your own forms to any project or task
- Streamline your projects and collect data by following ready-made form guidelines
- Use custom forms to meet your specific needs.
- Create any form you need in the project you need it.
Version TrackingKeep track on form versions:
- Approval history
- Approved version
- Version history
- Current version
- Draft Version
Built-in validationThe embed Validation, both in unique and required fields, can control and make sure your form elements are filled in the right, expected, correct way.
Input MaskEnsure specific format of data is entered, limit number of characters, allow only numbers to be entered…Input Mask prevents form to be filled with wrong data format.
Predefined fieldsCreate different types of custom fields, use predefined values to add prospect:
- Radio buttons
- Drop downs
- Multi select option
Variety of field typesForm builder allows you to create any field type:
- Basic components (text field, text area, number, checkbox…)
- List components (user list, version list, priority list)
- Special Components (email, phone, address, attachment button…)
Export collected records:
- Collect and maintain records in a nicely formatted and easy to read manner
- Convert to downloadable and printable PDF
- Chose layout that suits you best
- Option to preserve the privacy of sensible data
Approval WorkflowsPrevent users to use unfinished forms, or forms that are not adequately created by selected approval workflows.
Forms and RolesControl and manage Form Editing with defined Roles, this helps to make sure only adequate and qualified persons have access to modify.
Conditional logicUse logic to show or hide certain fields depending on the information entered. With this feature you will only see the relevant fields. Make viewing/ filling your form an easy task.
Advanced options for sensible designingPersonalize even the finest details with default specific codes- HTML Element components.
Not a Bolt-on System!QMS and project management are integrated together! You get BOTH!
Compliance is Both Top Down and Bottom Up.Foster a team based compliance culture and ensure everyone is involved, responsible and works together towards the desired quality outcomes.
Real-Time QMS VisibilityOversee any project or QMS related progress through the centralized QMS control. Simple and productive. Not adding another layer of bureaucracy, nor interfering/imposing upon the project routine, nor the employees’ daily routine.
Handle audit files with ease, organize your QMS and save your team 100's of hours of documentation and compliance work!
Quality ManualEstablish your quality manual in a day! Correlates directly to qmsWrapper and the Processes used. Edit, modify and keep it up to date with a few clicks.
Gap ReportFind gaps before the auditors do! Easily oversee what is in progress in which process and whether any item is pending, missing or needs further attention.
QMS Role Based SecurityHave the right level of access controls by using role based permissions that make sure the right people have access to confidential data, tasks, projects and associated content.
Electronic Signatures - FDA QSR 21 part 11When completing critical or high-importance actions, dual signature compliance functionality is used to securely and positively identify the authorized person.
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.
- Customize QMS Processes or SOPs to fit your company’s particular workflows.
- Build new processes from scratch, just by following few easy and simple steps.
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 Approval Workflows
- Automatic notifications keep the flow active.
- Instant status visibility, with full revision, details and version history.
- Change Control. Simple to verify and approve any document change.
- Customize or create workflows to meet FDA 510k or ISO 13485 compliance.
Electronic Trail for DataA signed document now has a date stamped electronic trail, that, if required, can be printed.
Tag ProcessesTag task as QMS process for easier follow-up and backtracking. See what tasks were undertaken to resolve QMS related issues within the context of the Project itself.
User Groups & Selective File SharingReduce risks before they happen, or mitigate an undesired event by putting in place action plan controls. Easily track the recurrence of issues, analyze the impact of controls and measure the effectiveness of your action plans, either short- or long term.
QMS Risk ReportingEnsure the right people are getting the right information to be effective by creating custom user groups.
Fully Integrated Both Into and with QMSForget about using separate software applications for handling projects and another for QMS. Enable project based collaboration to ensure FDA 510K or ISO 13485 team based compliance.
Balance Resources and Track Performance in Real TimeAssign the right work to the right team, with the right schedule to utilize resources more effectively. An open view of team workloads makes it easy to recalibrate when necessary.
Real-Time Project VisibilityHave instant visibility and traceability over your entire system operations at any stage of your project through the project summary report, including: roadmaps, Gantt chart, issue tracking details, etc.
Activity DashboardEasily manage your daily work through the personalized overview of your current activities: projects, tasks, to-dos, meetings, QMS issues, documents waiting for approval, notifications and more.
Flexible Workgroups & Customizable Roles for Each ProjectDesign a requirement specific dream-team for each project. Any combination of employees can be collected into a workgroup and users may play different roles in different projects. Flexible, effective!
Tags, QMS, Milestone, VersionsOversee how of complex projects activities are proceeding through Tags. Better organize projects, define issues, plan features and establish release dates.
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.
Custom WorkflowsSimplify completing residual tasks by creating your own Custom Workflows to match exactly how your team works. They’re easy to implement and simple to use.
Project Workflow EditorCustomize the default Project Workflows or SOPs to fit your company’s particular workflow needs, or build new processes/workflows from scratch, just by following few simple steps.
Unlimited ProjectsGet the flexibility you need to manage unlimited projects and subprojects, teams, tasks, issues, milestones, versioning, approval workflows, etc., all with one tool.
Subproject SupportDivide complex projects into easily manageable parts, like milestones, tasks and subtasks. The Subproject can inherit all properties of the parent Project.
Issue TrackingHave clear accountability and easily oversee activities through different product releases, including: requirement origins, assignee history, tags, who executed the task, who approved, which version etc.
One Ecosystem for All IssuesUnited interface and one system for every bug, issue, idea, or feature request
Integrated with StorageOrganize and automatically store all project related files, discussions and task in the actual project. QMS and projects follow each other in parallel – That is QMS compliance made easy!
Gantt–ChartView your project schedule and set dependencies in a real-time visual timeline. Adjust, filter and manage easily to keep your team on track.
Fully Integrated into and With the QMS & PM ModuleHave a complete and accurate picture of the risks across your products, processes, and teams with a complete risk assessment that is effective throughout your product’s entire lifecycle.
Flexible and IntuitiveProportionate the flexible system to match the complexity and type of your organization. Accidental risk managers and risk manager professionals can both benefit.
Hazard Control MatrixEffectively identify, evaluate and mitigate risks through the single matrix interface! Organized with action plan, analysis, charts, reports, follow-ups statistics, investigation and more.
Risk StatisticsHave all the hazardous situations, categories, harms and statistics on a single interface, graphically mapped out for easier handling and simple overview.
Risk Control ProcessesMake risk-aware decisions based on ISO 14971 guidance, that are built to help meet regulatory compliance and lessen the frequency/severity of failures.
ISO 14971 TemplatesSimple to use, easy to modify or create new from scratch. Each Risk is defined by a template based on ISO 14971 Standard, that can be modified and tailored to your company needs.
Risk IDsIdentify every Risk record with unique ID that helps to administer effective follow-ups. Risk categories and default classifications are based on Annex E of ISO 14971.
Risk identificationUncover, focus and describe as many of the foreseeable risk events that can lead to a hazardous situation, associated with the application of your device as possible.
CAPADrop CAPA process into the project, thereby trigger a special sequence of events required to resolve the QMS issue.
CAPA Follow UpEasily track CAPA back to its origins, reported through the QMS processes. A signed document, electronic or otherwise, now has a date stamped electronic trail, that if required can be printed.
InvestigationHave a comprehensive review of the desired outcomes of your CAPA, including issues regarding: human resource, equipment, management, product design, material, manufacturing processes etc.
Risk EvaluationSet severity of the harm and likelihood of occurrence of the harm and get automatically evaluated risk levels based on your organization’s predetermined risk acceptability threshold.
AnalysisBuild a database by collecting production and post-production information throughout your product’s lifecycle. With the complete detail summary of the hazard analysis, it’s easy to find the underlining issue of your problems.
Action PlansReduce risks before they happen, or mitigate an undesired event by putting in place action plan controls. Easily track the recurrence of issues, analyze the impact of controls and measure the effectiveness of your action plans, either short- or long term.
QMS Risk ReportingHave automated QMS event generated after each hazard or risk step. Easily overview all QMS activities and enforce the right actions, for example a document approval workflow by category.
Document Management & Control
Centralized, Secure, Cloud StorageKeep all your project files and critical compliance documents in the projects they were created, yet control, track and maintain complete visibility through a single storage, cloud repository.
SOPsUse default SOPs through Processes, or import your company specific ones, easy to modify or create entirely new, add them into any combination of folders or projects to meet your needs.
DHFsProduce the documents you need at each stage of production and simply generate your DHF.
Traceable File HistoryNo more chasing lost or missing records! Prove regulatory compliance with a complete document traceability and file version history. Have evidence that the audit requires on-demand.
Version/ Change ControlStop juggling multiple versions of the same document! Have complete document revision control through a centralized workspace, where everyone sees each other’s updates in real-time.
Drag and Drop Upload &DownloadUpload as many documents as you'd like at once, either in a chat, or a project, or attach them to a meeting with a simple drag-and-drop, while keeping track of each version.
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.
QMS Processes & DocumentationKeep your team on the compliance track through QMS Processes. Checkpoints are integrated into the documentation flow to help streamline your FDA or ISO compliance activities.
QMS VaultLock and store QMS approved files in a secure Vault. No delete or change permitted, required for FDA compliance, version and permissions controlled, with full QMS histories, ensures the integrity of your QMS is never compromised.
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.
Relate/Assign Documents to QMS FolderUse a process or manually relate/assign any storage file into the QMS Folder. Moved files are stored in the QMS Module, but for simplicity also remain viewable in the Storage.
Categorize, Classify, & TagHave fast and effective search listing results by marking your files/records with keywords and advanced metadata tags.
Advanced Document SearchEasily find a needle in the haystack! Any document can be listed and filtered by any parameters, including the search for documents related to specific processes, projects, sub-projects, tags, type of documents, etc., search results can be printed if required.
Cloud ViewerPreview your files online without a need to download the document. Quick viewing access!
Files Stored by ProjectsYou work in projects, so Central Storage stores your files by project. This way users know where to find their files. A document added in a Project related Topic chat, will be automatically saved in the corresponding project directory.
Check Out/ Check In filesAvoid confusion and unwanted multiple over-writes. Check out the file with a simple move and make sure no one else is making changes on the same document until you check it in again.
Internal Team Messaging
Integrated Team ComplianceGive your Team-Compliance a level up, where everyone works together towards the desired quality outcomes. Track project changes, capture meetings, flag QMS and design changes across all the software modules.
Real Time Chat ConversationsStay on top of your projects, documentation and QMS issues! No need for separate chat apps, no compatibility issues, no more losing focus from switching between apps.
Secure Internal CommunicationSend and receive secure communication through the internal encrypted team messaging.
Attachments Synced with StorageNo more searching for lost attachments! Files shared or sent in a Chat are automatically stored in the Document Management, and can be linked to a particular project. Compliance made easy!
1-on-1 ConversationPick somebody’s brain or get fast answers from a particular colleague in a private 1-1 chat conversation.
TopicsExecute faster across distributed teams using topic based, ongoing discussions with full context of the work. Easy to follow and reference for the record later. A document added in a Project related Topic chat, will be automatically saved in the corresponding project directory.
Group ConversationConnect your teams and accomplish complex tasks through campfire, group chats. Start brainstorming together.
To-dosNo pen? No problem! Create a quick ToDo in any conversation and schedule it. Easy to track and follow-through.
Meetings ManagementSchedule meetings, create agenda, send automated notifications to attendees, save meetings, add meeting minutes, assign and track follow up tasks. Maintain a record of all meetings and associated documents.
Save Any ConversationUse chat threads as a compliance document, link it to adherent project or task then complete it with meeting minutes, agenda, scheduling, follow-up, and special ISO and FDA attributions.
Chat HistoryEvery 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.
Integrated, Cloud, AvailableWe built every aspect of our QMS software with security in mind. Your data is protected and available whenever required, through a cloud-based system.
Data BackupsBuilt-in document versioning and continuous, encrypted, off-site multiple location/ GEO regions storage backups are protecting your data in case of disasters.
Software UpdatesRegular software updates protect the software from emerging security concerns.
EncryptionEncryption is done for data-in-transit ensuring your data integrity during every login, internal file interaction or external data synchronization.
Strong Authentication PolicyThe first step in your secure and robust information protection system. Including: minimum length and character variety, limits on reuse and so on.
Role-Based Access ControlSafeguards ensure only authorized persons can access data (whether in-house or in the cloud) and only in a way that is authorized by the Admin/Department Managers.
Administrative ControlsGranular controls and comprehensive reporting capabilities give you (Managers) ”centralized-user-management”, a control over what is shared with your team or with other users.
Closed SystemMaximize file security with a closed system, requires no API integration, ensures 3rd party can’t access your confidential project data, all file communications are secured.
Electronic Signatures - FDA QSR 21 part 11When completing critical or high-importance actions, secondary signature compliance functionality is used to securely and positively identify the authorized person.
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