Menu
We offer consulting services for the fluid implementation and enhancement of Qualification and Validation processes in the pharmaceutical industry. Our customized approach delivers an end-to-end solution for all Qualification and Validation demands
Our experts collaborate with your team to create a comprehensive landscape for qualification and validation activities. This involves mapping out the entire process, including identifying key stakeholders, defining roles and responsibilities, outlining regulatory requirements, and establishing timelines and milestones.
We develop detailed Validation Master Plan customized to your organization’s specific needs and objectives. These plans provide a roadmap for all validation activities, outlining the scope, approach, resources, and schedule for each validation project. Our goal is to ensure that the validation process is well-structured, efficient, and compliant with regulatory standards.
Our consultants conduct full GAP Assessments to evaluate your current practices against industry standards and regulatory requirements. This process identify potential GAPs, and areas for improvement.
Based on these findings, we develop strategies and action plans to address the potential GAPs and enhance the overall effectiveness of your qualification and validation activities.
We work closely with your team to define a strategic approach for Qualification and Validation activities.
Our strategy definition process ensures that your Qualification and Validation activities are well- aligned with regulatory expectations and best practices, enabling you to achieve optimal results while minimizing risks and maximizing efficiency.
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)
