The Fishbone Diagram
Is a systematic problem-solving tool used to identify, analyze, and visualize the potential root causes of a specific problem. In pharmaceutical and GMP environments, it supports Quality Risk Management (QRM), deviation investigations, CAPA, and continuous improvement activities. The diagram organizes possible causes into major categories such as Materials, Methods, Machines, Measurement, Environment, and People (6M approach), enabling cross-functional teams to evaluate all factors that may influence product quality, process performance, or compliance. By providing a structured and collaborative approach, the Ishikawa Diagram helps organizations identify the true root cause of problems, implement effective corrective actions, prevent recurrence, and strengthen overall quality systems.
GMP Documentation & Regulatory Consulting
At the highest level, the Site Master File (SMF) provides a comprehensive overview of the manufacturing facility, including organization, quality systems, production activities, utilities, equipment, and GMP compliance status. We support companies in preparing, reviewing, and updating SMF documents to ensure inspection readiness.
Quality Manual (QM)
defines the foundation of the Pharmaceutical Quality Management System (PQMS), including quality policy, objectives, responsibilities, and continuous improvement strategies. Consulting services help organizations establish a robust quality framework aligned with GMP principles.
Validation Master Plan (VMP)
establishes the overall validation strategy for facilities, utilities, equipment, processes, cleaning, and computerized systems. Our expertise assists companies in developing risk-based validation approaches compliant with regulatory expectations.
Consultation for GxP & GxxP Ecosystem
GxP Ecosystem Consultation is a strategic consulting service designed to help pharmaceutical, biotechnology, medical device, cosmetic, and healthcare organizations establish, improve, and maintain a fully integrated quality and compliance framework across the entire product lifecycle.
The term GxP represents a family of “Good Practice” requirements where x changes according to the activity, such as GMP (Manufacturing), GLP (Laboratory), GCP (Clinical), GDP (Distribution), GVP (Pharmacovigilance), and GEP (Engineering Practice)
Our work in numbers
Trained with us
275
Costumer
35
Qualified Projects
15
consultation
197
Contact Info
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