Human Error Detection Software Solution
For an Asia-based investigation management specialist for the pharmaceutical industry.
About
The client helps organizations analyze, assess and determine the human committed errors with a robust and sustainable system with effective Corrective and Preventive Actions (CAPA). They were in pursuit of a technology partner to digitize the investigation management mechanism with a modern web interface.
Capability
Enterprise Software
Industry
Healthcare
Country
India
Key Features
Rishabh enabled the client by developing Human Error Solution Software (HESS) to serve the highly regulated pharma industry. It helps improve human reliability, product quality, achieve regulatory compliance, and reduce risk.
Problem & investigation management
View, list, search, approve, store, discard, and download the list of problems with multiple problem types that can be filtered by investigation ID, issue type, date, status & other relevant parameters.
Dashboard & reports
Drive a culture of continuous improvement by generating reports that help resolve quality issues, avoid recurrence, execute containment actions and validate the efficacy of root cause elimination.
Workflow & task management
Automate & streamline a proper workflow for corrective and preventive actions to close issues on time and ensure consistent quality and strict compliance at every step of the quality control process.
Alerts & notifications
Faster issue management & acceleration of CAPA cycle time by addressing quality issues quickly and efficiently. Offers real-time collaboration for investigations with an update on reviews, approvals, action plans and schedules.
Challenges
- Absence of dedicated technology-based HE detection and investigation platform
- Addressing the wrong issues due to inadequate investigations
- Insufficient root cause analysis
- Ineffective Recommendations System
- Productivity loss & customer dissatisfaction
Solution
As an enterprise software development partner, we helped automate the manual process for HE tracking with a dedicated system and beyond conventional QMS. The process focused on two essential aspects; 1) Mapping of Error Code on the System 2) Creation of Operational Configuration management framework.
Defining configuration framework
Helped the client rectify and improve upon their product quality by configuring, implementing and integrating the following tools & adhering to compliances:
- Root Cause Determination Tool (RCDT)
- Cognitive Load Assessment Tool (CLAT)
- RCDT Corrective And Preventive Action (RCDT Recommendations)
- CLAT Corrective And Preventive Action (CLAT Recommendations)
- 21 CFR 11 compliance
Authorization & role permission management
Provided architectural guidance and implemented best practices to help streamline and automate the flow of data between crucial operational management systems along with an identity management database for:
- Roles & User Management
- Site Management
- Department Management
- Permission Management
Technologies Used
Project Snapshots
53%
speed-up of action process
43%
increase in reliability
100%
accurate audit trail for each process
Have a Project in Mind?
+1-877-747-4224
Got questions? Let's Talk
sales@rishabhsoft.com
Need help? Email us
