What is READY!?

READY! is a web-based solution comprising:

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.

READY! is a replacement for all those Excel spreadsheets that you are using now across your company.

Key facts:

  • A Common solution for all departments
  • 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.

What-is-READYREADY! will enable you to find approved and effective product information, plan and track your activities, and prepare comprehensive reports.

ISO IDMP Product Database

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

Our database can hold the information in EXVMPD and ISO IDMP formats simultaneously. This provides our clients an easy way to migrate from XEVMPD to ISO IDMP product submissions.

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

Our approach to implementing the ISO IDMP standards is based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organisations, and Referentials (SPOR) data:

  • 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.

Safety Database & ICSR

READY! can act as your safety database and you can easily handle your cases and receive alerts on important dates, keep track of your compliance with legal deadlines, and manage your ICSRs.

The ICSRs are compatible with the new ICH E2B(R3) standard including the connection to the Eudravigilance Gateway.

READY! enables comprehensive monitoring of all activities and documents required by the EU GVP, while respecting all technical requirements of EU and US regulators.

READY! helps you manage and control your implementations of safety variations, PSMFs, PSURs, DDPSs, RMPs, literature monitoring, adverse drug reactions and ICSRs, xEVMPD, and ISO IDMP submissions.

Electronic Document Management System

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, contracts, 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

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.

The READY! product database can be easily integrated with your existing eCTD publishing and document management systems, including those based on MS Sharepoint and EMC Documentum.

Activity Tracking

With READY! you can efficiently plantrack, and monitor activities – such as planned applications, on-going variations, renewals, and PSUR submissions.

Activities can be managed by and accessed from various departments including Regulatory AffairsPharmacovigilance, and Development and Quality.

Activities are directly linked to relevant products, and it is very easy to navigate them.

READY! can handle any activity and the list is configurable.

Automatic reminders and email alerts on relevant dates such as renewal date help users focus on their daily work and never miss any deadlines.

Activities can be grouped into projects, which also makes READY! a great project management tool.

You can archive and track your electronic submissions including eCTD& NeeS sequences, XEVMPD and ISO IDMP messages, and eMail correspondence.

The contents of each submission, including sequences, is displayed and accessed directly from READY!

Searching and reporting

The most interesting part of READY! for users and their managers is its comprehensive searching and reporting capability. All regulatory information (products, activities, submissions, tasks, projects, documents, etc.) is available within seconds.

All information is linked through hyperlinks, so it’s very easy to jump from a variation to a product, and to open eCTD submissions. Comprehensive search and reporting abilities will help you find information like: what is registered where; who is responsible; and what are the latest versions of approved and effective SmPC and PILs.

You will be able to find out what the on-going activities are, and if activities are being finished on time.

Complete regulatory activity reports give you comprehensive information about which person made what changes to your products.

READY! will even alert you or your boss about a deadline.

Time and cost tracking

Some companies want to collect information about how much time and money they have spent on their (regulatory) activities.

We have devoted a significant part of our efforts to support tracking time and costs spent on various activities. Some companies want to collect data about how much time and money they spend  to plan more efficiently. Others need this information to bill their services to their customers. READY! has built-in comprehensive time and cost registering and reporting.

You will be able to track and plan the time spent for each of your products, or simply find out how much time you need per variation time – on average. This is great for service providers preparing monthly reports for your customers – and bills will be issued much faster and more efficiently.

SPOR Master Data Management (ISO IDMP)

READY! architecture fully supports the IDMP data model and the new IDMP Controlled Vocabularies (SPOR).
READY! Can become your central product database and consistently manage your organization’s critical data from the single reference source.

Remove duplicates from your critical data, aggregate, consolidate, and distribute your products, organisation’s, controlled vocabularies data from READY!, and ensure your data is consistent across all IT systems in your company.

READY! can easily be integrated with the following systems:

  • Existing product databases
  • Document Management Systems, including MS Sharepoint and EMC/Documentum,
  • SAP, Oracle, and other ERP systems
  • Various tracking tools and RIM solutions
  • MS Excel-based data lists

The following integration interfaces are available for 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)

 

READY_for_IDMP-2017

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.

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