arivis started with the first ever eDMS system that integrated Business Process Management (BPM). We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Later we introduced more regulatory submission management capabilities with support for 510k, PMA, and custom submission types.
HIGHLIGHTS
Regulatory documents
DIA EDM Reference Model
Submission signposting
Lifecycle & workflows
Dynamic permissions
Metadata
Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).
HIGHLIGHTS
Scheduling enable the organizations to manage inspections
Mapping and tracking of observations to issues and CAPA items
Track progress and effectiveness of corrective measures
A timely, transparent, and effective communication between sponsors and authorities are paramount during regulatory operations in drug development and can facilitate earlier availability of safe and effective drugs to patients. At the same time, it reduces frictions with later steps in the approval process.
For further information please contact us, we look forward to hearing from you.
