In pharma, biotech and medical devices, computerised systems are critical. We implement and validate GMPConnect with a risk-based approach, for compliance and operational efficiency.
GMPConnect is a productised part of our CTO cleanrooms. Standardisation reduces validation effort and aligns the software with ADAPTUS hardware performance.
Systems that handle electronic records, batch data and real-time monitoring receive the highest validation level. Our CSV methodology:
Electronic records must stay complete, consistent, accurate and secure throughout their lifecycle. Controls include unique user logins, automatic non-alterable timestamps and attributable alarm acknowledgements.
Electronic records for GMP environments
EU GMP guidelines
Computerised systems validation
Risk-based GMP approaches
| Stage | Cleanroom | Software |
|---|---|---|
| DQ · Design | Design of facility, systems and equipment suits the intended purpose | Design review against user, functional and regulatory requirements |
| IQ · Installation | Installed according to approved specifications | Software and hardware installed and configured correctly |
| OQ · Operation | Operates across the defined ranges | Software functions tested against specifications |
| PQ · Performance | Consistent performance of required processes | Intended use verified under real operating conditions |
Cleanroom systems exchange data in real time.
A live virtual replica for better decisions.
Connected sensors keep cleanliness and stability in check.
One ecosystem for performance and energy savings.
Cleanroom data turned into actionable insight.
Learning models predict issues before they occur.
From design to installation and long-term support: cGMP compliance, environmental monitoring and full validation, for new facilities and upgrades.
Pre-engineered building blocks, circular design, validation, GMP monitoring, commissioning or remodelling: our team answers quickly and to the point.
