Covid-19

Regulatory Information & Submission Management software centralizes data and documents leading to strong Digitization helping Regulatory management efficiency and compliance risks reduction.

ViSU is a cloud based RIM Software for global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, UDI, eIFU, Reg Intel and many more.

Modules

Reg Intel

Leverage 80+ country specific regulatory requirements (covering Clinical, Registration, Life cycle, Labeling, Import/Export, Safety and other 150 data points). Subscribe to Regulatory monitoring to know country specific updates that links to your products for effective impact analysis and change control.

Reg Intel
Product Master

Product Master

Detailed information on Products captured and acts as a Central Repository for product information to serve as System of Truth. If you already maintain this info in other systems (like PLM, ERP), we have pre-built interfaces to manage push/pull easily.

Registrations & Tracking

With few clicks create new and manage life cycle if registrations in different countries. Intuitive project management attached to eliminate all excels or other tools for you to manage data, documents, and emails that relates to registrations and can be tracked by product, country, sku, franchise and more.

For larger product roll outs, create programs and assign to different teams (or economic operators with limited access) for a truly global program management.

Registrations & Tracking
Submissions

Submissions

Comprehensive solution to support entire submission life-cycle, from planning, authoring, publishing to archival. Streamline end-to-end submission development, gaining visibility and painlessly. Built-in 100+ Country specific plans and applications (for FDA, EU, Canada, LATAM, GCC, Asia) greatly reduces your “build/maintenance” time and also minimizes risk of rejections or queries.

Track progress of dossier build through actionable reports and dashboards, mitigating risks to submission time-lines. Publish submissions in zip or pdf or xml. Distribute through built-in cloud CMS (or push to your DMS) to internal or external stakeholders.

Commitments

ViSU creates auto commitments based on built-in country specific requirements and alerts you on pre-defined times so as to minimize missing events. User friendly reports and calendar views help manage these effectively.

Commitments
Correspondence

Correspondence

Create and track Agencies or HA Correspondence. Automate all entries with built-in email extractor that pulls different emails and links to your products. This will greatly minimize risk of losing emails or responses and ensure important info is not stuck in email boxes (or gone when people leave).

UDI

Prepare, Validate, Submit, and Track UDI Submissions of a product (initial &life-cycle). Product data gets converted and validated to different country requirements (presently supports FDA and EU EUDAMED).

UDI
Standards

Standards

Subscribe for Medical Device Standards and get alerts or updates on subscribed standards. Maintain your standards copies in central repository. Link alerts to products for proactive risk management.

eIFU/Labeling

Portal linked to Products with internal and public web pages with several languages included. Gain full control on what copy is where and maintain full compliance. Additional features include access control, remote print and more.

eIFU/Labeling
EDMS

EDMS

A modern Document Management System with all features included that acts as a central repository for all documents used in several modules of ViSU. If you already have EDMS, we can complement it with a link or do push/pull to ensure this compliments your system.


Modules

Reg Intel

Leverage 80+ country specific regulatory requirements (covering Clinical, Registration, Life cycle, Labeling, Import/Export, Safety and other 150 data points). Subscribe to Regulatory monitoring to know country specific updates that links to your products for effective impact analysis and change control.

Reg Intel

Product Master

Detailed information on Products captured and acts as a Central Repository for product information to serve as System of Truth. If you already maintain this info in other systems (like PLM, ERP), we have pre-built interfaces to manage push/pull easily.

Product Master

Registrations & Tracking

With few clicks create new and manage life cycle if registrations in different countries. Intuitive project management attached to eliminate all excels or other tools for you to manage data, documents, and emails that relates to registrations and can be tracked by product, country, sku, franchise and more.

For larger product roll outs, create programs and assign to different teams (or economic operators with limited access) for a truly global program management.

Registrations & Tracking

Submissions

Comprehensive solution to support entire submission life-cycle, from planning, authoring, publishing to archival. Streamline end-to-end submission development, gaining visibility and painlessly. Built-in 100+ Country specific plans and applications (for FDA, EU, Canada, LATAM, GCC, Asia) greatly reduces your “build/maintenance” time and also minimizes risk of rejections or queries.

Track progress of dossier build through actionable reports and dashboards, mitigating risks to submission time-lines. Publish submissions in zip or pdf or xml. Distribute through built-in cloud CMS (or push to your DMS) to internal or external stakeholders.

Submissions

Commitments

ViSU creates auto commitments based on built-in country specific requirements and alerts you on pre-defined times so as to minimize missing events. User friendly reports and calendar views help manage these effectively.

Commitments

Correspondence

Create and track Agencies or HA Correspondence. Automate all entries with built-in email extractor that pulls different emails and links to your products. This will greatly minimize risk of losing emails or responses and ensure important info is not stuck in email boxes (or gone when people leave).

Correspondence

UDI

Prepare, Validate, Submit, and Track UDI Submissions of a product (initial &life-cycle). Product data gets converted and validated to different country requirements (presently supports FDA and EU EUDAMED).

UDI

Standards

Subscribe for Medical Device Standards and get alerts or updates on subscribed standards. Maintain your standards copies in central repository. Link alerts to products for proactive risk management.

Standards

eIFU/Labeling

Portal linked to Products with internal and public web pages with several languages included. Gain full control on what copy is where and maintain full compliance. Additional features include access control, remote print and more.

eIFU/Labeling

EDMS

A modern Document Management System with all features included that acts as a central repository for all documents used in several modules of ViSU. If you already have EDMS, we can complement it with a link or do push/pull to ensure this compliments your system.

EDMS

Business Benefits

  • Increase global coordination and communication between functions and affiliates by sharing a common authoritative regulatory information source
  • Built-in Reg Intel to help plan for new products or new countries with regulations and checklists. Improve impact analysis decisions and country pathway planning
  • Eliminate Spreadsheets, tedious data-entry and manual cross-checking / reconciliation of data
  • Minimize compliance risks and business loss ( because of missed opportunities or delay in license renewals)

Technical Benefits

  • All Cloud and you can add/drop modules. Modular and simple pricing
  • Fully validated and compliant with 21 CFR part 11, GAMP and ISO 13485
  • Robust querying, dashboards and reports
  • Easy integration to your existing infrastructure
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