Sterile Environmental Monitoring Case Study
FDA 21 CFR Part 11 compliant environmental monitoring replacing legacy chart recorders with open data access.
Industry: Pharmaceutical
Quick Facts
| Attribute | Value |
|---|---|
| Customer | Hikma Pharmaceuticals |
| Location | New Jersey |
| Scale | 31 manufacturing plants, 7 R&D centres globally |
| Users | 15 total, 4 concurrent |
| Development | 1 month |
| Legacy System | Honeywell GR series graphic chart recorder |
| Compliance | FDA 21 CFR Part 11 |
| Integrator | Controlware, LLC |
The Challenge
Challenge: Replace closed non-expandable Honeywell GR series graphic chart recorder with an open, flexible system meeting FDA requirements for sterile environment monitoring.
Specific pain points:
- Old system recorded data in proprietary data structure
- Required separate product to access recorded data
- Less security and non-flexible reporting
- Closed stand-alone system couldn't share data with operations, quality analysts, planners
- Industry 4.0 requires better data access for production decisions (batch quality assessment, cleaning requirements, capacity planning)
- FDA 21 CFR Part 11 compliance required (audit trails, password rotation, e-signatures)
Impact: Proprietary data structures prevented efficient reporting and data sharing across the organization for quality and production decisions.
The Solution
Architecture
| Tier | Component | Capabilities |
|---|---|---|
| Field | PLCs, Sensors | Native CIP drivers, instrumentation |
| Building | Niagara Building Automation | OPC UA connectivity |
| Central | FrameworX (Windows 10 VM) | Trending, alarming, reporting, displays |
| Historian | InfluxDB + Canary Historian | Open source real-time data storage |
| Analytics | Grafana | Dashboard visualization |
| Collection | Telegraf | Data aggregation |
| Clients | Smart Client, Shop Floor Read Only | Remote access via HTTP/HTTPS |
Connectivity
| Protocol | Application |
|---|---|
| OPC UA | Niagara Building Automation |
| MQTT | Secure access to other systems |
| Native CIP | PLC communication |
| Influx Line Protocol | Historian data |
| .NET Client | Trend data to Grafana |
FDA 21 CFR Part 11 Features
| Feature | Implementation |
|---|---|
| LDAP Integration | Centralized authentication |
| E-Signatures | Electronic record verification |
| Audit Trails | Custom tracking of all changes |
| Password Policies | Rotation and strength requirements |
| Electronic Records | Database security and compliance |
Key Enablers
FrameworX capabilities that made this solution possible:
| Capability | Application |
|---|---|
| Built-in Historian | Canary Historian included |
| CFR Part 11 Features | LDAP, e-signature, custom audit trails |
| Open Environment | .NET scripting language |
| Enhanced Trending | Custom calculations and statistics (MKT) |
| Client-Server Model | Economical unlimited remote users |
| Redundancy | Included in base system |
| Multi-Source Data | Multiple data sources for trending/alarms |
| No Vendor Lock-In | Works with major PLCs and sensor vendors |
The Results
Replaced Physical Chart Recorders — Electronic records with database security and CFR Part 11 compliance
Open Data Access — Recorded data accessible via SQL and data historian APIs
Real-Time Access — Live values available via OPC UA and MQTT
Enhanced Trending — Custom calculations and statistics including MKT (Mean Kinetic Temperature)
Built-In Reporting — PDF and XPS format generation
Flexible Security — FDA 21 CFR Part 11 compliance out of the box
Remote Access — Reporting easier and faster with multiple remote clients
Redundancy — Data historian technology handles increasing loads while maintaining response
Customer Testimonials:
"FrameworX was the perfect SCADA platform to meet our sterile Environment Monitoring system requirements. Its built-in features, allow for full CFR Part 11 compliance out of the box. From the low-cost remote clients, integrated data historian, redundancy, and ease of customization, are key value adds, with no hardware vendor lock-in."
— Sam Khodak, Pharmaceutical Data Integrity Specialist
"FrameworX easily and cost effectively allowed us to handle many use cases and requirements that are hard and/or expensive to implement with other SCADA packages. It also contains multiple tools and interfaces for creating a modern flexible and open architecture system. The SCADA world is not just about working with PLC/Controllers anymore. FrameworX is built to integrate information from smart sensors, MES, ERP, and cloud. With its native .NET scripting, built-in drivers and data connectors, it allowed us to accomplish this without the need for third-party add-ins."
— Richard Benamy, Controlware
Resources
Download case study: CaseStudy_ChartRecording.pdf
This case demonstrates FDA 21 CFR Part 11 compliant environmental monitoring with open data access replacing legacy proprietary chart recorders.
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