Qualification and Validation
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
Creation of the QMS Landscape
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.
Validation Master Plan Development
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
GAP Assessments and Execution
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.
We offer end-to-end solutions regarding CSV, Cleaning Validation, Process Validation, Equipment Qualification and Water Systems Validation, including document creation, test execution, third parties management, access control, trainings, and data management.
Qualification and Validation
Routine Support
Qualification and Validation
Implementation and Improvement
Quality Leadership
Development Program
Our Customers
How does a collaboration work?
Collaboration is all about understanding and addressing your unique needs.
1. Appointment request
You request a free initial consultation via our website and answer a few questions.
2. Preliminary talk
One of our employees will talk to you over the phone about your request and put you in touch with the right contact person.
3. Virtual consultation
A strategy consultant will give you 60 minutes of individual advice on your situation and work with you to develop a solution to your problem.
4. Long-term cooperation
After the initial consultation, there is the option of us supporting you in the long-term implementation of your solution.
TÜV-certified
ISO 9001 Quality Management System
Consulting service in the field of pharmacy, medical technology and quality assurance
Supplier qualification in the field of pharmacy, medical technology and quality assurance.
Personnel qualification in the field of pharmacy, medical technology and quality assurance.
