Reducing task touch time by 50%-90% for compliance processes
The vision is to transform the MedTech Quality Management System through the power of AI and machine learning. As the project embarks on a mission to digitize the QMS to not simplify and optimize the approach to Quality & Compliance, Supply Chain and R&D. The primary objective is to eliminate the complexities and inefficiencies of data searches and manual transactions, empowering our team to focus on what truly matters – ensuring the highest standards of quality.
Augmented decision-making, powered by data-driven insights, will be the cornerstone of our digitized QMS, allowing us to combine the best of both worlds.
Pain Points
Complex workflows
Unnecessary rework loops
Manual inefficiencies
Unoptimized record-keeping
Workstream 1 (insights):
From:
Browsing through several systems and getting independent data to compare.
To:
AI infused browsing checking multiple systems in parallel
From:
Manual pattern review
To:
AI pre-review before final approval steps (clerical + process mandates)
From:
user generated action plans
To:
Context aware smart recommendations with timelines and dissemination recommendations, plus follow up notification triggers.
Challenge:
30+ Quality System technology applications
Varying levels of integration & data availability
Fragmented / duplicative data
Significant resource impact across all functions (including R&D and Supply Chain)
Increasing reliance on tribal knowledge
Diverting their time away from higher-value activities
Increasing the “cost of quality” activities
Solution:
Search through QMS applications across 500 systems to return real-time data
Automate initial incident assessment and recommendations
Auto-generate descriptions, narratives, reporting, and communications
Automate writing and standardize formats from Quality Innovation to the internal quality system to update records
Benefits:
Current cost state 6.2 M to 3.1M in one year for 2.7k records which is 70% cost reduction in trainings alone, 72% IMPROVED speed and efficiencies in workflow which gives 75% of time to focus on the customers.
99K+ Hours to 41k hours per year in CAPA, Audits, Escalations and ComplaintsImproved User experience drived 14k unqiue users every week after the launch of the product.UX metrics: 68% in CSAT; 74% IN UX LITE; 72% in ease of use.
Intangible benefits:
Reduce rework and near misses
Improve Time to Market
Improve long-term GP
Expand capacity to manage volume
Improve ability to react to change
Reduce Cost to Serve
Enhance Controls and Compliance
Earlier quality triggers
Improved risk management
Do more with less – grow the business without growing the workforce
Cognitive Services
Authentication integration (AD SSO)
Application will be productionized
Integrations – once established, switch to maintenance
