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Confluence is only a wiki to share information

While it may sound appealing to configure your team's current wiki tool (Confluence, Notion etc.) to use as an eQMS, this is very time consuming to set up and maintain, and configuring multiple plug-ins (e.g. for digital signatures) increases the price.

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Problems with the Confluence/Jira combination vs. TraceX solutions

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

INADEQUATE REGULATORY COMPLIANCE

TRACEX REGULATORY COMPLIANCE TAILORING: TraceX is specifically designed to comply with stringent medical device regulations like FDA 21 CFR Part 820, ISO 13485, and EU MDR, which Confluence is not inherently built for.

DISCONNECTED QUALITY PROCESS

TRACEX INTEGRATED QUALITY MANAGEMENT PROCESSES: TraceX integrates various quality processes like CAPA (Corrective and Preventive Actions), Non-Nonformities, and audit management, ensuring a cohesive approach to quality management.

LIMITED DOCUMENT CONTROL

TRACEX ADVANCED DOCUMENT CONTROL: TraceX offers superior document control features crucial for compliance, including version control, audit trails, and electronic signatures, which are more comprehensive than what Confluence provides.

COMPLEX CONFIGURATION FOR MEDTECH

TRACEX IS ALREADY CONFIGURED FOR MEDTECH: Configuring Confluence to meet the specific requirements of the medtech industry can be complex and time-consuming, often requiring extensive customization and third-party integrations.

CHALLENGES IN TRAINING MANAGEMENT

TRACEX DEDICATED TRAINING MANGEMENT: Ensuring that personnel are trained on the latest quality processes and product changes is vital in medtech, and TraceX includes features for managing and tracking employee training and qualification.

RESSOURCE INTENSIVE MAINTENANCE

TRACEX ONGOING MAINTENANCE AND UPDATES: Keeping Confluence properly configured and updated for medtech standards can be a continuous and resource-intensive process, especially as regulations and company needs evolve.

COMPLICATED REGULOATORY AUDITS

TRACEX STREAMLINED REGULATORY AUDITS: With better traceability and documentation control, TraceX simplifies the audit process, a key factor for regulatory compliance in medtech.

INEFFICIENT REPORTING AND ANALYTICS

TRACEX CENTRALIZED REPORTING AND ANALYTICS: TraceX enables more effective and comprehensive reporting and analytics for quality metrics, which can be more complicated to achieve in Confluence.

NEED FOR SPECIALIZED CUSTOMIZATION KNOWLEDGE

TRACEX NO EXPERTISE REQUIRED FOR CUSTOMIZATION: Specialized knowledge is often required to customize Confluence for medtech use, including understanding of compliance needs and technical skills for tool configuration.

NON CUSTOMIZABLE WORKLOWS

TRACEX CUSTOMIZABLE WORKFLOWS: TraceX allows for the customization of workflows to align with specific processes of a medtech organization, which is not a primary feature of Confluence.

LIMITED SCALABILITY

TRACEX SCALABILITY: TraceX solutions are more scalable, supporting company growth without changes to the system infrastructure.

INCREASE RISK OF ERROR

TRACEX REDUCES ERRORS AND INCREASES EFFICIENCY: Automating many quality management processes in TraceX reduces the risk of human error and increases operational efficiency.

DATA SECURITY AND INTEGRITY CONCERNS

TRACEX IMPROVES DATA SECURITY AND INTEGRITY: TraceX is designed with robust security features to protect sensitive medical data, which is crucial for compliance with data protection regulations.

TIME AND RESSOURCE INTENSIVE ADAPTATIONS

TRACEX NO NEED SETUP RESOURCE INTENSIVE WORKLOAD: Adapting Confluence to function effectively as an eQMS in the medtech sector can demand significant resources, both in terms of time and personnel, often detracting from core business activities.

LACK OF INDUSTRY SPECIFIC FEATURES

TRACEX INDUSTRY-SPECIFIC FEATURES: TraceX includes features specifically designed for the medtech industry, and will continue to evolve with that focus and not which is not Confluence case.

Want more information?

We would love to hear from you and see if TraceX can respond to your needs!

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