Specialized Services
Avaliação Detalhada
do Sistema da
Quality
Structured assessment based on risk management, GMP compliance analysis, identification of GAPs and definition of an action plan to adapt the quality system.
Assessment
Risk Based
Structured risk analysis in the quality system and GMP processes
Analysis
of Compliance
Verification of adherence to current standards
Identification
the GAPs
Mapping gaps in the quality system
Plano
of Action
Definition of corrective and preventive actions
Solutions for Regulated Industries
Pharmaceuticals, Cosmetics, Food, Health and Veterinary Products.
Global Scope
Performance aligned with the main national and international standards.
Expert
Team with extensive experience in regulated industries.
Process
Structured methodology for efficient assessments.
Flexibility
Personalized approach with high performance.
What is Strategic Diagnosis?
The Strategic GMP Compliance Diagnosis is a comprehensive and structured assessment that identifies the maturity level of your quality system in relation to GMP regulatory requirements. Through an analysis based on risk management, we map existing GAPs and define a prioritized action plan to ensure compliance and continuous improvement of your processes.
Who is this diagnosis for?
This diagnosis was developed for companies in the pharmaceutical industry and regulated sectors that need to evaluate the robustness and maturity of their Quality Systems in light of GMP/GMP requirements.
It is especially suitable for professionals responsible for ensuring regulatory compliance and process reliability.
Main profiles served:
• Quality Assurance Directors and Managers
• Quality Systems Managers
• Responsible for internal audits
• Supply Chain professionals and supplier qualification
Sectors served:
• Pharmaceutical Industry
• Manufacturers of pharmaceutical ingredients
• Medical devices
• Cosmetics
• Logistics companies and regulated services
How It Works
Our diagnosis follows a structured methodology in 4 steps to guarantee consistent results.
Initial Survey
Understanding the regulatory scope, mapping processes and existing documentation.
Compliance Analysis
Detailed assessment of the quality system against applicable standards and regulations.
Identification of GAPs
Gap mapping and classification by criticality and impact on the quality system
Action Plan
Definition of corrective and preventive actions with schedule and responsible parties.
Assess the maturity level of your Quality System
Contact us and discover how Strategic Diagnosis can transform your quality system at a global GMP level
Request Strategic Diagnosis