Quality Assurance

The combining of a product database and a document management system allows the integration of process management, 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
  • Complaints
  • Audits planning & support

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.

READY! provides:

  • A paperless environment
  • Remote access
  • Secure access
  • Secure digital archive
  • Improved productivity and the reduced impact of inspections and downtime
  • The ability to track actual performance against SOPs, quickly identifying deviations, and managing information about them in a single system.
  • The ability to effectively manage CAPA, enabling you to get accurate information and make the right decisions quickly
  • A single data repository making it easy to track, monitor, trend, and report on performance information
  • Workflow engine, electronic documents
  • SOP management (including Working instructions and Forms management)
  • SOP and Policy training
  • Product-related change management control (i.e., Labeling, SPC, PIL, mockups)
  • Deviations/Non-conformance Management
  • Corrective and Preventive Actions – CAPA
  • Customer Complaints management
  • Risk management
  • Change Control
  • Training records
  • Complaints
  • Audits planning & support
  • Electronic signatures according to FDA 21 CFR # 11

Document management and records archive

All regulated documents, including SOPs, are handled with READY! document management to make sure the users get approved and effective versions. Authors, reviewers, and approvers use electronic signatures and workflow to review and approve new document versions.

The document lifecycle and related workflows are automated and users get access based on document status and their access rights and document status.

Once approved, the documents can be distributed to the end-users using predefined Distribution Lists.

PDF renditions are generated automatically and can include Signature pages and Watermarks (Controlled Printing).

Responsible users will receive automatically generated emails reminding them about commitments, due dates, and document renewals.

The system in line with the FDA 21 CFR#11 requirements for digital signatures and includes a complete Audit Trail.