Quality Control Solutions for the Pharmaceutical Industry
Optimize drug manufacturing, ensure FDA and GMP compliance, and improve efficiency with WinSPC, Ignition, and MSA Gage Pro.
How WinSPC Optimizes Quality Control in the Pharmaceutical Industry
In the pharmaceutical industry, precision, traceability, and regulatory compliance are critical to ensuring product safety. WinSPC enables real-time statistical quality control to meet strict regulatory requirements.
- Statistical Process Control (SPC) in drug manufacturing.
- Compliance with FDA 21 CFR Part 11 and Good Manufacturing Practices (GMP).
- Automation of predefined or customized quality reports.
- Advanced security controls and password protection.
- Optimized quality control to reduce costs and minimize errors.
Ignition SCADA for Automation and Supervision in the Pharmaceutical Industry
Ignition is a SCADA, HMI, and MES platform that enables full integration of pharmaceutical production systems.
- Real-time monitoring of critical parameters such as temperature, pressure, and humidity.
- Compliance with FDA 21 CFR Part 11 through electronic records and digital signatures.
- Complete traceability of production batches with instantly accessible histories.
- Automation of alarms and alerts to prevent process deviations.
- Accessibility from any device with Ignition Perspective.
Benefits:
- Reduced regulatory risks through automated records and audits.
- Optimized time management and waste reduction with real-time monitoring.
- Seamless integration with ERP and production systems for full pharmaceutical process control.
Measurement Instrument Management with MSA Gage Pro
MSA Gage Pro is a SaaS platform designed for efficient calibration management and MSA studies in the pharmaceutical industry.
- Automation of calibration control for laboratory and production equipment.
- Complies with FDA 21 CFR Part 11, ISO 9001, and GMP.
- Automated alerts for calibration expirations and repeatability & reproducibility (R&R) studies.
- Secure access from any device, with no installation required.
Monitor pharmaceutical quality in real-time with specialized software for the pharmaceutical industry.
Comparison: WinSPC, Ignition, and MSA Gage Pro in the Pharmaceutical Industry
| Functionality | WinSPC | Ignition | MSA Gage Pro |
|---|---|---|---|
| Real-time Monitoring | ✅ Statistical Process Control | ✅ SCADA, HMI, and MES | ✅ Calibration Management |
| Regulatory Compliance | ✅ FDA 21 CFR, GMP, ISO 9001 | ✅ Digital signatures, traceability | ✅ Validation and audits |
| Process Automation | ✅ SPC in production | ✅ Automated alarms & reports | ✅ Calibration alerts |
| System Integration | ✅ ERP, LIMS, MES | ✅ PLCs, databases, sensors | ✅ Laboratory connectivity |
Success Stories in the Pharmaceutical Industry
Quality Control Optimization in a Pharmaceutical Plant
✅ Implementation of WinSPC for real-time statistical quality analysis.
✅ 30% reduction in process deviations and improved compliance with FDA audits.
✅ 30% reduction in process deviations and improved compliance with FDA audits.
Ignition SCADA Integration in a Pharmaceutical Production Line
✅ Real-time monitoring of temperature and pressure in reactors.
✅ Full compliance with FDA 21 CFR Part 11 through electronic traceability.
✅ Full compliance with FDA 21 CFR Part 11 through electronic traceability.
Success Stories in the Pharmaceutical Industry
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