Novus³ is supporting the South African Health Products Regulatory Authority (SAHPRA) in the next phase of its digital transformation: extending a secure, validated digital ecosystem for regulatory submissions, workflow management, data visibility, integrations, and operational support.
Digitisation of Clinical Trials Business Processes for Medical Regulators
Recent Use Case: The Comprehensive Digitisation of Business Processes for The South African Health Products Regulatory Authority (SAHPRA)
Ensuring the safety, efficacy and quality of health products in South Africa. In a regulatory environment where speed, confidence, and auditability matter, digitisation is not only an IT upgrade. It is an operational shift.
Through this project, Novus3 is helping SAHPRA extend its Engagement Portal and related digital platforms to support a wider set of regulatory business processes, including submissions, licensing, Section 21 permits, inspections, pharmacovigilance and post-market surveillance, clinical-trial oversight, lot release management, request management, and other client-facing interactions.
The work brings together secure workflow design, role-based access control, validated forms, data standardisation, dashboards, integrations, support services, and training. The result is a more connected digital environment where applicants, reviewers, managers, and support teams can work from clearer data and more traceable processes.
Our approach
Our approach begins with Workflow Digitisation, turning priority regulatory processes into structured, auditable digital workflows. Underpinning these are Validated Regulatory Forms that capture cleaner data through conditional logic, master data, and embedded business rules. We prioritise Integration and Interoperability, connecting portal data with document, analytics, finance, and operational systems, and layer in Dashboards and Reporting to give teams visibility over applications, workloads, performance, finance, and outcomes. Through Data Cleansing and eTracking, we move legacy spreadsheet trackers into controlled, relational data structures. Finally, we embed lasting adoption through Training and Support, delivered via role-specific training, documentation, and knowledge transfer.
What you get
- Digital workflow modules for priority SAHPRA regulatory processes, including submissions, renewals, amendments, permits, inspections, surveillance and service requests.
- Configurable application and review workflows that support screening, referral, assessment, outcome setting, applicant queries, timestamps, and audit trails.
- Dynamic, validated forms with conditional logic, controlled reference data, and business rules that improve data quality at the point of capture.
- Integration with core regulatory and operational systems, including document and submission-management platforms, analytics environments, payment and finance processes, and relevant data sources.
- Dashboards and reporting to improve visibility over workloads, throughput, financial tracking, application status, product tracking, KPIs, and management oversight.
- Migration from spreadsheet-based trackers toward validated, relational tracking structures that create a more reliable source of operational truth.
- Training, support, and knowledge-transfer mechanisms that help SAHPRA users adopt and sustain new digital workflows.
- A validation and quality approach aligned to recognised regulated-system practices, including GAMP 5, CSV principles, 21 CFR Part 11, EMA Annex 11, POPIA-aligned privacy controls, and structured SDLC documentation.
Key benefits
- Manual and fragmented processes: Structured portal workflows and centralised tracking deliver less duplication, clearer ownership, and fewer blind spots.
- Complex regulatory forms and review paths: Dynamic forms, business rules, and configurable workflows enable better data capture, faster routing, and stronger auditability.
- Limited operational visibility: Dashboards, reporting, and data warehouse integration provide near real-time insight into workloads, status, risks, and performance.
- Spreadsheet-based trackers: Relational eTracking and data cleansing create a stronger source of truth with validation, access control, and traceable updates.
- Adoption and change risk: Role-specific training and support ensure users are better equipped to operate new systems confidently and consistently.
Get in touch
Gauteng
Cnr. Lynnwood & Botterklapper St., Die Wilgers, Pretoria, 0081
Western Cape
97 York St, Dormehls Drift, George, 6529