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We offer support for the execution of all activities related to Qualification and Validation routines, including Computerized Systems Validation, Equipment Qualification, Cleaning Validation, Process Validation, Validation of Water Systems
Our team specializes in qualifying equipment to ensure its suitability for pharmaceutical manufacturing processes. We conduct thorough assessments, testing, and documentation to verify that equipment meets regulatory standards and operational requirements.
We offer end-to-end solutions regarding CSV, including document creation (according to GAMP5), test execution, third-parties management, access control, trainings, and data management. Our experts ensure that these systems meet regulatory requirements and industry standards, covering aspects such as data integrity, security, and functionality.
Support for Cleaning Validation activities to ensure that equipment and facilities are effectively cleaned and free from contamination. Our services include protocol development, and sampling plans, to demonstrate the effectiveness of cleaning processes.
Our team assists in Process Validation to ensure consistent product Quality and compliance with regulatory requirements. We develop validation protocols, and execute validation studies, to confirm the robustness and reliability manufacturing processes.
We provide support related to strategy and document creation to Water Systems Validation, to ensure the quality and purity of water for various applications.
Digital Solutions (Computerized Systems) – Implementation and Improvements
Digital Solutions (Computerized Systems) – Routine Support
Qualification and Validation – Implementation and Improvement
Computerized Systems Validation Landscape – Implementation or Improvement
Master Data Management (Computerized Systems) – Strategic Consultancy
Access Management (Computerized Systems) – Strategic Consultancy
Implementation of a new Computerized System – Strategic Consultancy
Computerized Systems Validation Audit Readiness – Strategic Consultancy
Computerized Systems Validation Audit Readiness – Routine Support
Quality Management Systems Landscape – Implementation or Improvement
Quality Management Systems Audit Readiness – Strategic Consultancy
Water Systems Validation (WFI, PW and Pure Steam) – Strategic Consultancy
Water Systems Validation (WFI, PW and Pure Steam) – Routine Support
Computerized Systems Validation Landscape – Operational Documents Creation
Master Data Management (Computerized Systems)– Strategy Definition
Computerized Systems Implementation – Project Management with Quality Focus
Computerized Systems Validation Audit Readiness – Strategy Definition
Computerized Systems Validation Audit Readiness – GAP Assessment
Master Data Management (Computerized Systems) – Workshop and Trainings
Access Management (Computerized Systems) – Workshop and Trainings
Computerized Systems Validation Audit Readiness – CAPA Plan Management
Computerized Systems Validation Audit Readiness – Audit Execution
Computerized Systems Validation Audit Readiness – Workshop and Trainings
Quality Management Systems Landscape – Operational Documents Creation
Water Systems Validation (WFI, PW and Pure Steam) – Strategy Definition
Water Systems Validation (WFI, PW and Pure Steam) – Operational Documents Creation
Water Systems Validation (WFI, PW and Pure Steam) – GAP Assessment
Water Systems Validation (WFI, PW and Pure Steam) – Project Management
Water Systems Validation (WFI, PW and Pure Steam) – Workshop and Trainings
Medical Devices EU Registration – Implementation and Improvement
Nitrosamines: Compliance with requirements - Implementation and Improvement
Safe use of AI tools in Quality: Data Security and Process Optimization
Nitrosamines – Drug Substance Risk Management Strategy Creation (for NDSRI)
