Monitoring
GMPConnect monitoring software
In highly regulated industries such as pharmaceuticals, biotechnology and medical devices, computerized systems are essential to ensuring product quality, patient safety and data integrity. At ABN Cleanroom Technology, we implement and validate GMPConnect, using a risk-based approach that ensures compliance while optimizing efficiency. Our risk-based approach focuses validation efforts on systems that directly impact compliance, product quality and patient safety. Critical systems—such as those managing electronic records, batch data and cleanroom monitoring—receive the highest level of validation to ensure their reliability and compliance.
Our methodology begins with a system impact assessment, identifying whether a system plays a critical role in regulatory compliance, patient safety or product integrity. Once the impact is determined, we conduct a structured risk assessment and classification to define the necessary level of validation. Next, we develop a comprehensive validation strategy tailored to regulatory expectations, ensuring that critical system functions are rigorously tested.
We then execute Computerized System Validation (CSV) to confirm that the system operates correctly and maintains data integrity. Finally, we implement ongoing monitoring and periodic reviews to guarantee continued compliance with evolving regulations.
Why Computerized System Validation (CSV) matters
Ensuring that your computerized systems are fit for their intended use is a fundamental regulatory requirement. Therefore, we provide comprehensive CSV services, offering confidence that your GMPConnect system operates as expected and that the data it generates is reliable and secure.
For industries such as pharmaceutical manufacturing, biotechnology, medical devices, and food production, compliance is non-negotiable. Our risk-based validation approach ensures that your efforts focus on the most critical areas, reducing unnecessary costs and delays while maintaining full regulatory compliance.
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.
Design Qualification (DQ)
Cleanroom qualification
Documented verification that the proposed design of facilities, systems, and equipment is suitable for the intended purpose.
Software qualification
Design review.
Installation Qualification (IQ)
Cleanroom qualification
Documented verification that a system is installed according to written and approved specifications.
Software qualification
Checking, testing, or other verification to demonstrate correct: – Installation of software and hardware – Configuration of software and hardware (See Appendix D5 for details)
Operational Qualification (OQ)
Cleanroom qualification
Documented verification that a system operates according to written and approved specifications throughout specified operating ranges.
Software qualification
Testing or other verification of the system against specifications to demonstrate correct operation of functionality that supports the specific business process throughout all specified operating ranges. (See Appendix D5 for details)
Performance Qualification (PQ)
Cleanroom qualification
Documented verification that a system is capable of performing the activities of the processes it is required to perform, according to written and approved specifications, within the scope of the business process and operating environment.
Software qualification
Testing or other verification of the system to demonstrate fitness for intended use and to allow acceptance of the system against specified requirements. (See Appendix D5 for details)
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
Food processing
Food processing
Sanitary
Easy-Clean
Food-grade
Contamination Control
Regulatory Compliant
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.
What our clients say
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. Let’s find the best cleanroom solution together!
E-mail us
info@abn-cleanroomtechnology.com
Call us
+32 (0)89 32 10 80
Book a meeting
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Where you can find our productised cleanroom solutions
