1. Overview
A leading pharmaceutical company faced challenges in maintaining product quality and complying with strict FDA regulations. As the quality inspection process was still paper-based, the company experienced issues such as recording errors, approval delays, and difficulties in generating compliance reports.
To overcome these challenges, the company sought a digital quality inspection solution that could automate processes, minimize human errors, and ensure accurate, transparent, real-time compliance monitoring and reporting.
2. Challenges
Manual paperwork: Quality inspection and approval forms were handled manually, increasing the risk of data loss and errors.
Lack of standardization: Inconsistent inspection procedures across facilities led to data discrepancies.
Compliance risks: Delays or errors in reporting could result in FDA non-compliance.
No real-time tracking: Inspection data was not updated instantly, hindering timely analysis and decision-making.
Time-consuming approvals: Manual validation and approval steps slowed down the quality control workflow.
3. Solution
BAP developed a Quality Inspection App built on Microsoft Power Apps, specifically designed for the pharmaceutical industry to fully digitize the quality control process.
Key features:
Automated inspection workflow: Inspectors can input data and capture photos directly via mobile devices, eliminating paper forms.
Automated approval integration: Using Power Automate, inspection approvals are routed and processed automatically.
Real-time compliance reporting: Data is synchronized instantly and visualized in Power BI dashboards for management insights.
FDA compliance assurance: The system was built to meet 21 CFR Part 11 requirements, ensuring full FDA compliance.
Cross-platform accessibility: Supports both web and mobile access, enabling flexible field operations.
4. Technologies Used
Microsoft Power Apps – Custom inspection app development
Power Automate – Automated approval and workflow management
Power BI – Real-time compliance visualization and analytics
Microsoft Dataverse – Secure data storage and management
5. Results
80% error reduction by eliminating paper-based processes.
100% FDA compliance, ensuring product quality and trust.
50% faster report approvals, accelerating decision-making.
Improved transparency and data traceability, empowering efficient management oversight.
6. Conclusion
The Quality Inspection System developed by BAP using Microsoft Power Apps has successfully transformed a manual quality control process into a fully digital workflow.
This solution not only minimized human errors and accelerated approvals but also ensured FDA compliance—strengthening the company’s foundation for sustainable growth in the global pharmaceutical industry.
