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    SharePoint or similar can only store and share documents

    Storing your QMS documents in a Cloud Storage Service (e.g. SharePoint, Google Drive, DropBox, etc.) works well for storing documents but is very limited for all you need to do in our MedTech Regulated industry.

    With TraceX, you benefit from online document storage and collaboration as well as all the other     next generation eQMS capabilities.

    Your team will thank you and will appreciate using a centralized solution that will help them save a lot of time!

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    Problems with SharePoint or similar vs. TraceX solutions

    By switching to TraceX, a lot of your current problems will disappear. Find here some examples.

    REGULATORY NON COMPLIANT

    TRACEX EASES COMPLIANCE WITH REGULATIONS: TraceX is designed with regulatory requirements in mind, such as FDA 21 CFR Part 820, MDR EU 2017/745, ISO 13485, IEC 62304, etc., which are crucial for medtech companies.

    AUDIT CHALLENGES

    TRACEX ENABLES AUDIT READINESS: TraceX has built-in audit trails and electronic signatures, ensuring that all actions are logged and can be easily traced.

    FRAGMENTED LIFECYCLE TRACKING

    TRACEX STREAMLINED PRODUCT LIFECYCLE OVERSIGHT: TraceX provides integrated Product Lifecycle Management specific to medtech, ensuring comprehensive quality control, unlike generic cloud services which lack this specialized support.

    MANUAL QUALITY MANAGEMENT

    TRACEX SUPPORT FOR QUALITY PROCESS : TraceX is purpose-built to support quality processes like CAPA, change control, and document control, providing a more streamlined approach than SharePoint or similar, which is way too generic.

    DOCUMENTATION CONTROL WEAKNESSES

    TRACEX IMPROVES DOCUMENT CONTROL: TraceX has stronger version control, approval workflows, and access control features than SharePoint or similar, tailored to the standards required in medtech.

    LACK OF VALIDATION

    TRACEX COMES PRE-VALIDATED (CSV): TraceX is validated to comply with industry-specific requirements (Computer System Validation), ensuring the integrity of electronic records and electronic signatures.

    INADEQUATE TRAINING MANAGEMENT

    TRACEX INTEGRATED TRAINING MANAGEMENT: TraceX includes training modules that ensure employees are trained on the latest versions of SOPs and can track training completion, which is a critical compliance requirement.

    CHANGE MANAGEMENT HUMAN ERRORS

    TRACEX BETTER CHANGE MANAGEMENT: TraceX offers robust change management workflows that ensure changes are properly documented, reviewed, and approved.

    POOR TRACEABILITY

    TRACEX IMPROVES TRACEABILITY AND LINKAGE: TraceX allows better traceability between different components, e.g. linking nonconformities to CAPAs or documents together.

    LIMITED ANALYTICS AND REPORTING

    TRACEX ANALYTICE AND REPORTING: TraceX comes with advanced reporting and analytics tools that provide insights into the quality process, which are more elaborated and and focus on medtech audits than those available in SharePoint or similar.

    SCALABILITY ISSUES

    TRACEX CREATES SCALABILITY: TraceX is designed to grow with your company, accommodating an increasing number of users and records without a loss in performance.

    USER ADOPTION RESISTANCE

    TRACEX USER-FRIENDLY INTERFACES: TraceX provides a modern, user-friendly interface, which can improve user adoption and efficiency.

    MISSING INDUSTRY-SPECIFIC FEATURES

    TRACEX INDUSTRY-SPECIFIC FEATURES: TraceX offers features tailored to the medtech sector, such as adverse event reporting, product lifecycle management, and design control, which are not the focus of SharePoint or similar.

    INADEQUATE DATA PROTECTION

    TRACEX DATA SECURITY: TraceX provides robust security and privacy controls to comply with healthcare regulations, surpassing the general security measures of standard cloud storage services.

    OBSTACLES TO CONTINUOUS IMPROVEMENT

    TRACEX CONTINUOUS IMPROVEMENT: With a Medtech focus, TraceX is designed to support continuous improvement processes, with functionality to easily track, measure, and enhance quality performance over time.

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