READY! enables our client to integrate the business processes, documents, and products into one integrated web-based solution – which is being used among different deparments: QA, RA, R&D, PhV, and Production.
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?
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.
We have devoted significant efforts 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.
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.
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.
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:
The combining of an Product Database and a Document Management System allows, READY! to integrate the management of processes, documents, and products into one integrated platform – which is being shared among business functions: 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:
READY! in QA is designed to deliver real business benefits and low implementation cost:
From initiation to closure, READY! captures, records, routes, and verifies completion and approvals in the entire CAPA process.