RIMS - Registration Information Management Software

Get an overview of registrations and all related information

A comprehensive registration information management solution designed for multinational companies and wherever large amounts of registration information need to be managed. The application is in English (globalized i.e. easy to prepare for any culture), accessible via the web. It is possible to purchase a permanent license or just rent it.

Basic workplace

The user is provided with a workplace that resembles Outlook. The basic folders are:

  • Active Ingredients,
  • National Registrations,
  • Products,
  • Registration Procedures.

The table with the found data allows to search using the filter line, new data are signalled in bold font. Red colour indicates a task for the current user, blue a group task and green a task due to a crowd. Double-clicking opens the corresponding record and the data can be updated.

RIMS - Basic workplace

Records of active substances

The active ingredient is the key ingredient in the drug. It is used to further describe a medicinal product, which is a category of product. For example, it allows medicinal products to be grouped according to the active substances they contain.

Product records

The product is the product whose registration data we want to track. Can contain 0... n active ingredients. The key entry for a product is the type:

  • cosmetics,
  • food supplement,
  • medical device,
  • drug.

See other fields on the form:

RIMS - description of the registered product

Records of registration procedures

The form varies according to the type of product (drug, cosmetic, medical device or food supplement). The form for a medicinal product looks like this:

RIMS - records of registration procedures

The registration procedure results in national registration in 0 .. n countries, see the following form:

RIMS - national registration form

Registration of medicines is done by sending eCTD sequences. These are are recorded on the Sumbissions form.

Records of submissions

ECTD sequences sent to the regulatory authority. In the EU, they may apply to multiple countries simultaneously. They can apply to multiple products at the same time.

RIMS - sequence detail form

Details of the eCTD sequence.

RIMS - sequence detail form

More detailed data on the status of processing in each country:

RIMS - form for more detailed data on the status of processing in each country

Records of PSURs

The application allows you to record data related to PSUR reports for each registered product.

RIMS - PSUR record form

Artwork records (designs, 3D models of boxes, flyers)

The application allows you to keep files for each registered product of the following types:

  • blister, label,
  • box design,
  • PIL ...

RIMS - artwork file registration form

Evidence of attachments

Kromě předloh krabičky, příbalového letáku apod. je možné evidovat soubory dalších typů:

  • 3d model,
  • local document,
  • a general common document,
  • MA.

RIMS - attachment registration form

Evidence of remaining data and deadlines

The form is used to keep track of appointments and all other data that may be used by the user useful to the attendant.

RIMS - form for recording appointments and other data

Security settings

The application allows you to define company branches and assign individual employees only according to the regional scope of the branch.

RIMS - form for recording dates and other data

Readiness for change - Orgnes

The entire application is ready to go just by setting it up with the workflow engine Orgnes. Further changes can be made on the fly by simply changing the rules.


Orgnes - RIMS module:

  • It is a Windows network application (accessible via the Internet).
  • It is installed without administrative permissions by simply clicking on a link in an email, for example.
  • The application server can be in the cloud or in your company.