AURA represents an industry-first solution that delivers strategic value by automating traditionally burdensome tasks. It transforms the audit planning process into a streamlined, efficient, and effective operation, providing significant cost savings and enabling better focus on critical areas.
AURA was conceived as a response to the growing complexity and regulatory demands within the pharmacovigilance landscape. As companies expand globally, they encounter diverse geographic systems and regulatory environments, leading to potential gaps in audit coverage and risk exposure. Traditional methods of risk assessment, characterized by manual and time-consuming processes, are insufficient to meet these challenges. AURA creates a solid foundation for enabling new directions and innovation.
By automating key tasks such as data collection, risk scoring, and reporting, AURA enhances the quality and strategic impact of audit planning. This evolution not only saves time but also allows QA teams to focus on higher-value activities.
ADAMAS Consulting’s AURA (Audit Universe Risk Assessment)
Client Success Story: Top 10 Pharma Client
AURA’s capabilities were put to the test with a top 10 pharmaceutical client, whose audit universe was growing in size and complexity. The project uncovered 400 audit candidates from an initial 10,000 contact details, highlighting the inefficiencies of traditional methods.
“The response rate exceeded 80%, a remarkable achievement for this kind of exercise.” Amanda Sibley, Director Pharmacovigilance, GVP Compliance
This successful implementation not only improved audit coverage but also revealed previously unaudited entities, helping to prevent potential inspection findings.
Proven Advantages of AURA
The AURA process is underpinned by the expertise of a seasoned team adept at defining audit universes and identifying critical risk factors. The system automates numerous steps, from data collection to algorithm-based risk scoring, providing clients with structured, data-driven outputs to justify their risk based rationales during regulatory inspections.
- Efficiency: Automation reduces manual effort and time.
- Cost Savings: Estimated 30-50% savings compared to manual processes.
- Scalability: Greater benefits with larger audit universes.
- Compliance Confidence: Structured, data-driven results that stand up to inspection scrutiny.
By eliminating outdated manual workflows, AURA provides the visibility, control, and agility global QA teams need to manage risk with confidence.
Expanding Horizons: The Future of AURA
The evolution of AURA is only beginning. ADAMAS is actively exploring its integration into other GxP domains — from Good Clinical Practice (GCP) to Good Manufacturing Practice (GMP). These developments promise to extend AURA’s impact across the full spectrum of regulated activities.
At the core of AURA’s success is the ADAMAS Consulting team — a group of QA and technology experts united by a shared commitment to innovation, compliance excellence, and client partnership. Their expertise ensures that AURA continues to evolve in step with the industry’s most demanding standards.
Setting a New Standard in Risk-Based Audit Planning
With AURA, ADAMAS Consulting is redefining what strategic audit planning can achieve. By combining deep regulatory insight with intelligent automation, AURA transforms compliance from a reactive obligation into a proactive advantage.
AURA is not simply a technological upgrade — it is a leadership statement for organizations that demand precision, transparency, and control in a complex global regulatory environment.
