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READY!

 

READY! = REgulAted Information DiarY!

 

Pharmaceutical companies are using READY! to increase productivity and compliance in collecting, tracking, and submitting product information and documents according to the latest regulatory requirements.

With READY! you will able to migrate your data from Excel and Share drive to READY! database.

KEY FACTS

Accurate and fast exchange of information

Easy-to-use web interface

ISO IDMP compatibility

Integrated security

Comprehensive audit trail

Data Exchange Gateway (XEVMPD & IDMP)

It can be used in various EU and non-EU regulatory activities for human and veterinary medicinal products, medical devices and APIs.

READY! is easy to implement and validate. The solution is based on our 20 years of experience in the pharmaceutical industry.

READY! has been developed using web based Microsoft technology (.NET and MS SQL Server).

It runs on computers (including Apple), smartphones, and tablets.

Product Database

The READY! product database enables secure collecting and sharing of medicinal product information across the company using a simple web interface.

The READY! product database can hold the information in XEVMPD and ISO IDMP formats simultaneously.

READY! supports human and veterinary medicinal products, OTC, medical devices, API, vaccines, and homeopathic products.

READY! is a proactive approach to managing, archiving and preserving your regulatory documents and electronic submissions.

EDMS is tightly integrated with our ISO IDMP Product database.

READY! is a powerful source of your regulatory information. End users like it because it is easy-to-use, and getting information is user-friendly.

 

Our approach to implementing the ISO IDMP standards is based on the four domains of master data in pharmaceutical regulatory processes.

 

Substance data

Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.

Product data

Harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information).

Organisation data

Data that is comprised of the organisation name, and location address data for organisations such as MAH, sponsors, regulatory authority, manufacturers.

Referential data

Lists of terms (controlled vocabularies) used to describe attributes of products e.g. lists of dosage forms, units of measurement, and routes of administration.

A Document Management System

READY! is a complete Electronic document and dossier management system (EDMS) including automated workflow, electronic signatures, audit trail and version control, document templates creation, documents PDF rendering, controlled distribution and searching on documents attributes and their content.

EDMS is tightly integrated with our Product database.

READY! is a proactive approach to managing, archiving and preserving your regulatory documents and electronic submissions.

Pharmaceutical companies have to handle a large number of regulated documents including SmPCs, PILs, mockups and various procedures and records.

Special focus is on structured documents such as dossiers, agreements, audits, inspections, deviations, complaints, change control, CAPA and PSMF.

 

Our integrated Document Management System includes:

  • Version control
  • Standard and custom Attributes
  • Lifecycle management
  • Automated workflow
  • Role-based security
  • Electronic signatures (FDA 21 CFR #11)
  • Audit trail
  • Templates management
  • Automated distribution
  • Automatic PDF rendering
  • Strong Search and Reporting capabilities
  • Dossier management

ISO IDMP standards are the cornerstone of READY!

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

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

A user-friendly web interface helps to navigate and manage your product information in XEVMPD and ISO IDMP format simultaneously.

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

  • A web user interface and IDMP product database to manage and clean-up product information
  • Full support for SPOR, including interface to EMA API
  • An integration service for data retrieval, validation, and standardisation of product data from various data sources
  • A HL7 gateway for exchanging messages with regulatory authorities
  • Automatic validation of data prior to submitting
  • Tracking and management of all sent and received messages
  • Master Data Management

READY! covers full support for ISO IDMP:

  • Full support for XEVMPD and the ISO IDMP standards
  • Automatic creation of XML messages for Article 57 in XEVMPD and ISO IDMP formats
  • An easy-to-use web interface that can track the status of XML messages
  • Automatic, two-step validation of product data and XML messages
  • Automatic submission of messages via built-in HL7 Gateway
  • Automatic error handling
  • Presentation of XML data into Word and PDF formats
  • The user-friendly web interface manually collects product information (for those companies without a backbone product database or tracking tools)
  • Drop-down lists are based on EMA’s controlled vocabularies (SPOR)
  • MEDDRA support
  • Strong change management capabilities (handling variations, updates, errors)
  • Support for product lifecycle management
  • Full reporting capabilities
  • Easy search
  • Export of data to Excel
  • Import of data from Excel
  • Import of XEVMPD messages (for migration purposes etc)
  • Export of XEVMPD messages
  • Import of IDMP/SPL messages (for migration purposes etc)
  • Export of IDMP/SPL messages
  • Security policy and access control
  • Handling of controlled vocabularies
  • Handling of user roles and groups
  • Life cycle management of medicinal product with regulatory status, version, and dates (change date, effective date, version date, etc.)
  • Automatic alerts