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Compliant Supervisory Control and Qualified Building Automation for Life Sciences
Monitor, record, and control regulated processes with an automation platform designed for security that supports GMP compliance and provides integration flexibility for pharmaceutical, biotech, and medical device manufacturing.
Get in touch with us: 508 543 8600
Industry Challenges
Life Sciences manufacturers face unique operational demands. Pharmaceutical, biotech, and medical device companies operate in one of the most heavily regulated manufacturing environments in the world. Every data point, every process parameter, and every operator action must be documented with absolute integrity. The cost of compliance failures extends beyond regulatory penalties to patient safety and public trust in life-saving therapies.
Regulatory Demands
FDA 21 CFR Part 11 and EU Annex 11 impose strict requirements
Data Integrity
Growing focus on data integrity and electronic records
Traceability
Complex processes require complete traceability and audit trails
Non-Compliant OT
Operational technologies are often not designed for compliance
Cleanroom Control
Cleanroom and environmental monitoring allow zero deviation
Validated Performance
Performance must improve while maintaining a validated state
Why Traditional Approaches Fail
Traditional automation and paper-based systems fall short. The life sciences industry invested heavily in automation systems that predate modern data integrity requirements. Many facilities still rely on paper-based documentation or hybrid systems that create compliance vulnerabilities. When regulators examine electronic records and audit trails, these legacy approaches reveal gaps that can result in warning letters, consent decrees, or worse.
- Create data integrity risks and audit trail gaps
- Rely on manual documentation prone to errors and omissions
- Lack integration between process control and quality systems
- Make deviation investigations time-consuming and costly
- Struggle to support electronic batch records and signatures
- Require extensive revalidation for any system changes
Solution Overview
Secure by Design and Built for Regulated Environments
The GENESIS automation software platform connects and contextualizes operational data across:
- Pharmaceutical, biotech, and medical device production assets
- Central utilities, laboratories, and warehouses
- Cleanrooms and environmental monitoring systems
- Existing enterprise, maintenance, quality, and laboratory systems
- Electronic batch records and recipe execution
- Multi-site global manufacturing operations
What You Can Achieve
Monitor critical process parameters in real time
Reduce deviation risk with proactive alarming and trend analysis
Capture complete audit trails with electronic signatures
Increase operational efficiencies and accelerate batch release
Improve productivity without compromising validated state
Ensure data integrity for regulatory inspections and audits
Key Use Cases
- Production monitoring and supervisory control
- Environmental and cleanroom monitoring
- Critical process parameter trending and alarming
- Electronic records and recipe execution
- Equipment qualification and validation support
- Integration with MES, LIMS, and quality systems
- Global multi-site operations visibility
Real-World Results
CSL Behring
- Regulated biopharmaceutical manufacturing monitoring
- Integrated quality and production visibility across plasma-derived therapies
- Global multi-site operations supporting life-saving treatments
Read the full CSL Behring success story.
Thermo Systems
- Laboratory and controlled environment monitoring
- Critical parameter tracking for life sciences applications
- Environmental monitoring solutions for research facilities
Read the full Thermo Systems success story.
Animal Healthcare Company
- Batch, QA/QC, and regulated facility monitoring
- Improved compliance documentation and traceability
- Streamlined audit preparation for veterinary pharmaceutical operations
Read the full Animal Healthcare Company success story.
Why Choose Mitsubishi Electric
- Built for FDA and EMA regulated environments
- Supports 21 CFR Part 11 and EU Annex 11 compliance
- Complete audit trail and electronic signature capabilities
- Integrates with MES, LIMS, and quality systems
- Scales from single facility to global enterprise
- Validation-friendly architecture minimizing change control burden
Digitize Your Life Sciences and Pharmaceutical Operations
Maintain compliance while improving efficiency and reducing risk.