Menu
We offer support for the execution of all activities related to Quality System routines, including Batch Record review, Change Control management, CAPA and Deviation management, and Internal Audits execution. With our partnership, we ensure that your Quality Systems remain efficient, compliant, and aligned with best practices, without delays or lack of SOPs adherence
Our team assists in managing Change Control processes, ensuring that any proposed changes to processes, procedures, or systems are thoroughly evaluated, documented, and implemented in compliance with regulatory standards. We facilitate the review and approval of requests, assess potential impacts on quality, and oversee the execution of approved changes.
We provide support in investigating and managing deviations from established processes or specifications, identifying root causes, and implementing corrective actions to prevent recurrence. Our consultants guide the deviation investigation process, facilitate cross-functional collaboration, and ensure timely resolution to minimize impact on product quality and compliance.
We assist in the implementation of corrective and preventive actions (CAPAs) derived from deviation investigations, audits, or other quality events. Our team helps develop CAPA plans, track progress, and verify effectiveness, ensuring that identified issues are addressed comprehensively to prevent recurrence and improve overall quality systems.
Our experts ensure that batch records are complete, accurate, and compliant with regulatory requirements, identifying any discrepancies or deviations that may impact product quality or regulatory compliance.
Our team plans, executes, and reports on internal audit activities, identifying areas for improvement, verifying the effectiveness of corrective actions, and ensuring ongoing compliance and continuous improvement.
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)
