Strengthening Compliance through Version Management Automation for Medical Devices
Automate version management of medical device manuals to reduce translation costs and ensure compliance with regulations.
In the medical device industry, strict version control and traceability management of manuals are essential to ensure product safety and reliability. Compliance with regulations is the foundation for business continuity. Inadequate version management can lead to product recalls and legal liabilities. IXIA CCMS supports strict operations that eliminate human errors by visualizing the entire document lifecycle. This enhances compliance and reduces risks. [Usage Scenarios] - Revision and approval processes for manuals in medical device manufacturers - Compliance with regulations (e.g., QMS, ISO13485) - Efficient management of multilingual manuals [Benefits of Implementation] - Immediate reporting of the history required for audit responses - Prevention of risks associated with the publication of unapproved content - Prevention of accidents due to translation omissions - Reduction of revision costs and release timelines
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【Features】 - Automatically records "when, who, which item, and how it was corrected" for each topic, instantly generating reports with the necessary history for audit compliance. - Enforces the drafting, review, and approval processes within the system, physically preventing the risk of unapproved content being published. - Automatically sets "update flags" for all affected translation language topics when the source language is revised, preventing incidents due to translation omissions. - Applies corrections related to regulatory changes across all manuals in a unified manner, significantly reducing revision costs and time to release. 【Our Strengths】 For over 20 years, we have been a pioneer in content management software, providing innovative solutions. We are a global leader in developing and selling technical document solutions based on the DITA standard.
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Creation of user manuals Creation of service manuals Delivery of dynamic documents tailored to end-user profiles
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For over 20 years, IXIASOFT has continued to demonstrate its role as a pioneer in content management software, providing innovative solutions for managing, sharing, and delivering exceptional content. Founded in 1998 as a technical spin-off of CEDROM-SNi, a major news information distributor in Canada and France, IXIASOFT now offers advanced software solutions to thousands of users in over 20 countries. IXIASOFT is a global leader in developing and selling technical documentation solutions based on the DITA standard. IXIASOFT Co., Ltd. was established in 2017 as the Japanese subsidiary of IXIASOFT Technologies Inc. in Canada.