PMRA eRecords & Document Management System

We designed and developed a secure electronic records and document management system for the Pharmacy and Medicines Regulatory Authority (PMRA), the statutory body established under the PMRA Act No. 9 of 2019.

The Challenge

PMRA needed to replace paper-based filing with a centralised, cloud-accessible portal for regulatory documentation — from product registration dossiers and clinical trial applications to pharmacy licensing and inspection reports.

Our Solution

The platform digitises PMRA's core regulatory documentation with:

• Secure eRecord storage with role-based access controls
• Structured document workflows enforcing creation-review-approval chains
• Full version control with detailed audit trails
• Advanced search and retrieval tools across the entire records catalogue

Impact

For a regulator tasked with safeguarding the quality, safety, and efficacy of every medicine entering the Malawian market, the system replaced a fragmented paper trail with a single auditable digital backbone — bringing the kind of records governance expected of a modern pharmaceutical regulatory authority.