RAMS Customer Release Notes

Release 2.26                                                                                           May 22nd, 2025

Introduction

Thank you for being a valuable customer of RAMS. We are excited to announce our most recent updates and improvements to the platform in our continuous efforts to serve you better. The following list outlines the four main sections of this document. Each section contains important information about this RAMS release. For detailed help instructions, please visit the RAMS Help Center.

  1. What’s New
  2. Updates or Improvements
  3. Bug Fixes
  4. Known Issues

 

1. What’s New

Representation Resources

  • A new sub menu "Service Guides & How To" has been introduced to provide more service and RAMS feature specific support tools and resources for Emergo’s representation clients.  

LMS Training Module: 

  • 3 new courses have been added to the list of trainings available under Trainings Module making the total to 8 courses. 
  • The Training Module will be available for free as complimentary service: 
    • To All New & Existing REP Account users
    • To All Commercial Accounts with an active Pro or Pro Plus service subscription

2. Updates or Improvements

Registration Tracker: 

  • In Registration Tracker records page, in the existing filter options, the following additional options have been added: 

    • Device class

    • Record Type

    • Version

    • Alert timeframe

    • Local representative

    • Local distributor

  • Under RT, we have ensured that the exported table of records and sorted table within the application reflect the same sorting and filtering options. 

Regulatory Reports:

  • Updated regulatory reports of following markets:

    • Australia

    • India

    • Saudi Arabia

    • South Korea

    • Switzerland

Regulatory Watch 

  • Account Settings – Regulatory Watch country selection has been moved to the Preferences tab within Account Settings. 

Product Classification: 

  • For European Union (MDD and MDR) markets, in the questionnaire section, the system will allow only "Yes" or "No" check box similar to other markets.  

Smart Docs: 

  • Column preferences selected by the user will be retained upon logging back in after logging out.
  • Upon clicking on “Create,” an option to add a new folder will now appear.   

Account Settings: 

  • Only Rep Account Owner and Rep Editor will be allowed to request address update via account settings.
  • In User's Registration Tracker (RT) service permissions, the following options are removed as they are filter options in RT module.
    • Records with Attachments
    • Affected by Regulatory Alert
    • Approval Date
    • Expiration Date
    • Country
    • Clear All

  • Rep accounts will be distinguished with the label “Rep Account”.

  • When a client cancels their last representative service with Emergo:
    • Client users will immediately lose access to RAMS features included within the scope of the representation service(s).
    • To continue using premium features within RAMS, clients will need to initiate a paid subscription to the platform features that are of interest.  

Smart Builder

MX Standard Route:

  • In addition to the dossier that is exported from SB, two forms will also be generated (in Word format) with the appropriate fields filled in, from various Nodes in the SB.
    • The forms:
      • COFEPRIS Form-Prefilled-04-001-F.docx - Data from Administrative Information Node. This output will be inserted right after “FORMATO DE SOLICITUD Y COMPROBANTE DEL PAGO DE DERECHOS” frontpage on the output file.
      • Registration Design of COFEPRIS.docx would replace the current Registration Design output file and will be available as a separate downloaded file.
  • The following new question has been added:
    • "Will Emergo be the Mexican Registration Holder?"
      • If "Yes", fields will be "prepopulated with Emergo Mexico's information in fields that require information about the Mexico Registration Holder and a new question will be asked as below:
        • "Do you have an agreement with a Mexican distributor that is not your Mexican Registration Holder?"
      • If “No”, fields will be prepopulated with Emergo Mexico’s information. 
  • In the output, Authorization Form will be included in the Application form before the contents page.
  • "AuthCertVisits.docx" has been renamed to "AuthorizationForm.docx".
  • RegistrationDesign.docx" file has been added in the output.
  • A new node “Authorization Certificates and Visits” (Node 11) has been added in the builder which will be used to preview the contents of authorization form.
  • Label design and Registration Design pages changes are made to the output in order to fetch the data from storage facility details under administrative Information.
  • Administration Node has additional changes to fill in the details in authorization form. The details are as below:
    • Federal Commission for the Protection against Sanitary Risks / Authorizations, Certificates and Visits.
    • Homoclave, name and modality of the procedure
    • Owner's details
    • Details of the establishment
    • Legal representative(s) and authorized person(s)
    • Supplier or Distributor Data/ Information for Sanitary Registration of Health Supplies.
  • Details of the facility that will condition or store the health supplies are also a part of Admin information node. 

Smart Exchange  

  • Upon project cancellation, client will receive an email notification with the following details:
    • Client’s Name
    • Device (Product) Name
    • Project Type  

3. Bug Fixes

  • N/A

4. Known Issues

  • N/A