The combining of an IDMP Medicinal 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! for 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
- Adverse events
- Risk management
- Change Control
READY! for QA is designed to deliver real business benefits and low implementation cost:
- 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.