READY! in QA ensures an integrated approach to content, process, and quality management requirements.
Special attention is given to process elements of Quality Assurance system, such as:
This allows READY! to provide detailed process insight and an audit trail to business users, enabling them to identify trends and improve processes.
All regulated documents, including SOPs, are handled with READY! 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.
READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
Development
Track milestones and store documents created in the development of a new medicine.
Quality Assurance
Manage processes, documents, and products in one integrated platform.
Are you READY! ?
Manage product information, safety data, and documents in one validated environment.
READY! is based around the idea that companies need updated, current information about their products in all of their iterations.
READY! has been developed to meet specific needs of management of structured (IDMP medicinal product information) and unstructured information (documents, forms, records) in pharma industry.
