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Department solutions

READY! enables our client to integrate the business processes, documents, and products into one integrated web-based solution – which is being used in their different departments, including: QA, RA, R&D, PhV, and Production.

READY! in Regulatory Affairs

READY! provides a regulatory database and tracking of daily activities for your Regulatory Affairs Department.

READY! focuses on the most efficient way to plan, track, and monitor all regulatory activities and tasks.

Reminders and alerts help users focus on their daily work, never missing any deadlines.

All information is interconnected through hyperlinks, so it’s very easy to jump from a product to a variation or submission.

What is READY! in Regulatory Affairs?

  • ISO IDMP medicinal product database
  • Regulatory tracking system
  • Planning and project management tool
  • Searching and reporting tool
  • Electronic archive of documents
  • Electronic archive of submissions (sequences)
  • Time- and cost-tracking tool

READY! will enable you to update product information, manage your regulatory activities, and prepare comprehensive reports.

All regulatory information (products, activities, submissions, tasks, projects, and regulatory documents) is available within seconds on your computer or mobile device.

Reports

We have devoted significant effort into providing comprehensive search and reporting capabilities.

READY! helps you quickly find information – like what is registered where and the status of each product, activity, and document.

For example:

  • An overview of Product Information (SmPC, PIL, labelling) per product and country with defined regulatory statuses
  • An overview of current labelling in the packs on the market (per product and country)
  • An overview of all planned, active, and finished RA activities (new MAA, variations, renewals, etc.)

Time tracking

Some companies want to collect data about how much time they spend on regulatory activities to plan more efficiently. Others need this information to bill their services to customers.

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 on average. This is meant for service providers preparing monthly reports for their customers, and so billing will be much faster and more efficient.

READY! in Pharmacovigilance

The pharmacovigilance department benefits from fast and easy creation of documents by exploiting all benefits of electronic templates, workflows and automatic data population.

READY! enables your company to comprehensively monitor activities and documents required by the EU GVP, while respecting all technical requirements of EU and US regulators (such as 21 CFR Par 11 or EU Annex 11), thus providing a tool for achieving regulatory compliance.

 

READY! provides:

  • Medicinal product database
  • Full support for XEVMPD and the coming ISO IDMP submissions
  • Change management and alerting
  • An overview of all company products (in development and later including regulatory status – authorised, pending registration, change ownership, suspended, etc. – marketing status, sunset clause, launch date, MAH, country, etc.)
  • QPPV and local representative per product and country
  • PSMF location per product
  • An overview of products belonging to DDPS, PSMF, or products with no DDPS or PSMF
  • Life cycle management of PSMF with annexes, SOPs, and quality manuals (versions, document status, responsibilities, etc.)
  • Life cycle management of risk management plans per product with their regulatory status, version, and dates (change date, effective date, version date, etc.)
  • PSUR cycles
  • DLPs per product
  • An overview of PSURs per product and country
  • Plan and track submissions of all PV-related activities (renewals, PSURs, safety variations, changes to RMP, etc.)
  • An overview of product information (SmPC, PIL, labelling) per product and country with defined regulatory and internal statuses
  • An overview of current labelling in the packs on the market (per product and country)
  • An overview of products with additional monitoring
  • An overview of literature search per product: global or local
  • An overview of clinical trials
  • An overview of PASS
  • An overview of all partners per product (formulation development, clinical studies, pharmacovigilance, in-licence, out-licence, co-marketing, etc.)
  • An overview of audits and inspections per product or PV system
  • An overview of all planned, active, and finished regulatory activities

Moreover, the system alerts you EVERYDAY which activities and tasks you need to complete to avoid delays and non-compliance.

Last, but not least, and still very important:

  • Standard and general reports
  • Reports that can be tailored and customised to an organisation’s specific needs
  • Export of reports to a different format (e.g. Excel, .xml, .pdf, etc.)
  • Possibility for various searches, general or customised, private, or public where you can access the required information with one click
  • Managers will have the prompt knowledge of dedicated activities, tasks, and projects for each employee to help them identify the people they need to achieve their organisational objectives

READY! in Quality Assurance (QA)

The combining of a Product Database and a Document Management System allows READY! to integrate the management of processes, documents, and products into one integrated platform – which is shared among business functions, including: QA, RA, R&D, PhV, and Production.

Special attention is given to process elements of Quality Assurance, such as SOP management, CAPAs, Deviations, and Audits.

This allows READY! to provide detailed process insight and an audit trail to business users, enabling them to identify trends and improve processes.

READY! in QA ensures an integrated approach to content, process, and quality management requirements, including:

  • SOP management (including Working instructions and Forms management)
  • SOP and Policy training
  • Product-related change management (example: Labeling, SPC, PIL)
  • Workflow across business functions
  • Deviations/Non-conformance Management
  • Corrective and Preventive Actions – CAPA
  • Customer Complaints management
  • Risk management
  • Change Control

READY! in QA is designed to deliver real business benefits and low implementation costs:

  • Improved productivity and reduced impact of inspections and downtime
  • Ability to track actual performance against SOPs, quickly identifying deviations, and managing information about them in a single system.
  • Ability to effectively manage CAPA, enabling you to get accurate information and make the right decisions quickly
  • A single data repository makes it easy to track, monitor, trend, and report on performance information
  • Includes a Workflow engine, form templates, configurable Controlled Vocabularies, and business process administration
  • Easily configurable to integrate into your environment without a heavy implementation cost

From initiation to closure, READY! captures, records, routes, and verifies completion and approvals in the entire CAPA process.