Cleanroom Monitoring System
GMPConnect Monitoring Software
In regulated industries such as pharmaceuticals, biotechnology, and medical devices, computerized systems are critical. Our cleanroom monitoring system help protect product quality, patient safety, and data integrity. At ABN Cleanroom Technology, we implement and validate GMPConnect using a proven risk-based approach. This ensures compliance while improving operational efficiency. As a result, your cleanroom monitoring system delivers reliable performance and ongoing compliance.
The Configure-to-Order (CTO) Advantage in Monitoring
GMPConnect is a pre-validated, productized component of our Configure-to-Order cleanroom solutions. This standardization guarantees reliability, reduces validation effort, and aligns the software directly with the performance of your ADAPTUS hardware.
Risk-Based Validation for Highest Impact
Our modular cleanroom solutions focus validation efforts on systems with the greatest impact on regulatory compliance, product quality, and patient safety. Systems that manage electronic records, batch data, and real-time monitoring receive the highest level of validation. This ensures accurate performance and compliance with industry standards.
Our methodology for Computerized System Validation (CSV) is structured and risk-based:
- System Impact Assessment: Identifying whether a system plays a critical role in regulatory compliance, patient safety, or product integrity.
- Structured Risk Assessment: Conducting classification to define the necessary level of validation.
- Validation Strategy Development: Developing a comprehensive strategy tailored to regulatory expectations, ensuring critical system functions are rigorously tested.
- CSV Execution: Confirming that the configured system operates correctly and maintains data integrity.
- Ongoing Monitoring & Review: Implementing periodic reviews to guarantee continued compliance with evolving regulations.
Ensuring data integrity in GxP Systems
Data integrity is at the core of regulatory compliance. Your electronic records must be complete, accurate and secure throughout their entire lifecycle.
Our GMPConnect validation services ensure that your data meets ALCOA+ principles making it Attributable, Legible, Contemporaneous, Original and Accurate to maintain compliance and prevent unauthorized modifications.
To protect data integrity, we implement system controls, including:
- Restricted data deletion capabilities to prevent unauthorized changes
- Unique user logins to ensure accountability
- Automatic timestamps that cannot be altered
- Time synchronization with a secure, central time source for consistency
At ABN Cleanroom Technology, we align our services with key regulatory guidelines, including:
- FDA 21 CFR Part 11 – Electronic records
- FDA 21 CFR Parts 210 & 211 – GMP regulations for pharmaceuticals
- EudraLex Volume 4 – EU GMP guidelines
- ISPE GAMP 5 – Best practices for computerized systems validation
- ISPE Baseline Guide Volume 5 – Risk-based approaches for GMP environments
Ensuring compliance and system reliability
In regulated industries, ensuring that systems and equipment function correctly and meet compliance requirements is essential. The GAMP 5 (Good Automated Manufacturing Practice) framework provides a structured approach to system validation, aligning with traditional qualification methodologies. Using the Configure-to-Order model makes compliance easier to achieve and more reliable over time.
Design Qualification (DQ)
Cleanroom qualification
Documented verification that the design of facilities, systems, and equipment is suitable for the intended purpose.
Software qualification
Structured design review to confirm alignment with user, functional, and regulatory requirements.
Installation Qualification (IQ)
Cleanroom qualification
Documented verification that the system is installed according to approved specifications.
Software qualification
Verification through checking and testing that software and hardware are installed and configured correctly.
Operational Qualification (OQ)
Cleanroom qualification
Documented verification that the system operates according to approved specifications across defined operating ranges.
Software qualification
Testing to confirm correct operation of software functions against defined specifications.
Performance Qualification (PQ)
Cleanroom qualification
Documented verification that the system can perform required processes consistently.
Software qualification
Verification that the software supports intended use under real operating conditions, backed by configured reliability.
Our industries
At ABN Cleanroom Technology, we know that every industry demands a unique approach to contamination control and environmental precision. Our productised cleanroom solutions are engineered to meet all the required standards. Explore our tailored cleanroom environments, each designed with specific features to ensure optimal performance, quality, and compliance in your industry.
High-Tech
High-Tech
Particle-free
Temperature Control
Humidity Control
ESD Protection
Laminar Flow
Life Sciences
Life Sciences
Aseptic
Controlled Environment
Laminar Flow
Temperature Precision
Contamination Control
Pharma
Pharma
Sterile
HEPA Filtration
Pressure Differentials
Validation
Regulatory
Manufacturing
Manufacturing
Customizable
Robust
ISO Compliance
Controlled Environment
Quality Control
Aerospace
Aerospace
Laminar airflow
ESD-safe surfaces
Low-outgassing materials
Climate control
Airlocks & gowning rooms
Battery
Battery
Temperature Control
Humidity Control
Explosion-proof
Process-specific
Safe Design
Revolutionize your cleanroom with AI-technology
We integrate Artificial Intelligence (AI) to revolutionize cleanroom performance. AI-driven systems enhance predictive maintenance, energy efficiency, and contamination control, ensuring optimal conditions with minimal human intervention. By leveraging real-time data and machine learning, we enable smarter airflow regulation, automated anomaly detection, and adaptive process optimization.
Let's talk cleanrooms
Whether you’re looking for expert advice, a quick answer, or a detailed discussion, we’re here to help. Choose the option that works best for you: call us directly, send us an email, or book a 30-minute meeting at your convenience.
E-mail us
info@abn-cleanroomtechnology.com
Call us
+32 (0)89 39 67 24
Book a meeting
Book a 30 minute meeting