PROMAP Clinical is our proprietary document workflow platform. Via a shared cloud-based portal spanning all the partners in the supply chain, it supports the transfer, storage, review and approval of all supply chain documentation including:
- Manufacturing Site Audit reports
- Qualified Person Declaration of GMP Compliance
- Investigational Medicinal Product Dossiers
- Clinical Trial Approvals
- Artwork Specifications and Label-copy
- Copies of Master and Executed Batch Records
- Certificates of Analysis / Compliance
- Shipping Documentation
- Temperature Data Records
Conscious of the frequent need for urgent shipments to Clinical Sites, the platform is designed to facilitate fast, efficient and safe release of product through a secure, digital environment.
The system is fully qualified (21 CFR Part 11 and EU GMP Annex 11).