ISO IDMP/Article 57 Reporting

Using READY! for Article 57 Reporting is not an additional burden for Pharmacovigilance and Regulatory professionals.

There is no need to keep a separate tool for Article 57 Reporting when using READY!

Since its creation, the structure of READY! and controlled vocabularies have been based on ISO IDMP/SPOR standards.

Submitting Article 57 data is just one click away, based on the data in the READY! Product database.

The data is automatically validated, and if it’s OK it is automatically submitted to the EMA.

Acknowledgments are automatically processed, including 3rd ACK.

“Did you know that one of the largest Article 57 Reporting installations is based on READY!?

Sandoz, the largest European generic company, has automatically validated and submitted more than 500,000 messages using READY!.

Their implementation has been smoothly up and running since 2012.”

Read their success story.

Our existing and new clients will have no problem using READY! for Article 57 Reporting based on the EMA requirements published in February 2020.

We are just including some additional data fields, such as Packaging and Manufacturing details and various Product IDs.

The ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human and veterinary use.

EMA is implementing the IDMP standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organisation, and Referential (SPOR) master data (link).

READY! is based on ISO IDMP standards and SPOR controlled vocabularies.

ISO IDMP/Article 57 submissions are standard out-of-the-box functionality of READY!.

The reliable exchange of medicinal product information is done with a click on one button. 

Our existing and new clients will meet the new EMA IDMP requirements (draft) published in February 2020 without a problem. Data fields, such as packaging and manufacturing details, are already an integral part of READY!.

READY! comprises the following main elements enabling full support of ISO IDMP requirements:

  • An integration service, for data retrieval, validation, and standardisation of product data from different data sources.
  • A web-user interface and IDMP product database to manage product information
  • Automatic validation of data prior to submitting
  • Integrated Gateway
  • Automatic handling of messages
  • Tracking and management of all sent and received messages
  • Master Data Management
  • Integration services with other systems including SAP

READY! architecture fully supports the ISO IDMP data model, the SPOR Controlled Vocabularies, and forthcoming product submissions using the HL7 standard.

READY! is easy-to-use, and all of the complexity of the ISO IDMP is hidden from the end-user.

READY! provides:

  • Full support for SPOR
  • Packaging information
  • Manufacturing details
  • An easy-to-use web interface
  • Proper data granulation
  • Management of attachments (documents)
  • A dropdown list based on SPOR vocabularies
  • Automatic data import
  • Bulk updates
  • Automatic message compilation
  • Message preview in Word and PDF
  • Automatic validation based on validation rules
  • Automatic submissions
  • Automatic status tracking of each message
  • Automatic handling of exceptions
  • Automatic handling of errors
  • Automatic messages versioning
  • Automatic handling of acknowledges
  • Automatic user notification
  • Product data import
  • Product data export

Efficiency

The focus is on re-using information for authorised products. A typical example is re-using/sharing identical information among MRP/DCP registered products with the same formulation. By doing this, the same data does not need to be managed and updated for each separate authorised product.

The result is a significant reduction in the time and staff needed to collect and maintain information.

Our existing clients report an estimated 20% increase in overall efficiency using READY!.

This can be translated into 20% more scientific work done instead of handling Excel spreadsheets and can be measured with the salaries of an additional 20% of staff.

Investment into READY! returns in less than one year!

Looking through this perspective, the ISO IDMP/Article 57 Reporting is one of the benefits of using READY!, and not an additional cost and a burden.

Integrations

The following integration interfaces are available for the secure exchange of information:

Web services
(Over plain HTTP or by using the SSL connection)

FTP and SFTP interfaces

(Optionally can be also used XLS message format)

Excel imports

READY! can be integrated with various systems:

  • Existing product databases
  • Document management systems
  • SAP, Oracle, and other ERP systems
  • Various tracking tools and RIM solutions
  • Automatic import of MS Excel-based data list

Our experience with xEVMPD implementation projects and the regulatory area have enabled us to provide the optimal ISO IDMP solution for the pharmaceutical industry.