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Services

Sophia Quality Solutions offers services and expertise in the following areas:

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  • Contract Qualified Person services can be provided to meet the clients specific needs.

 

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  • Release of Medicinal Products and Medical Device Products to the market place.
  • Preparation of Quality Documentation e.g. Product Quality Reviews, Quality Manuals, Quality Agreements.
  • Implementation of corrective action and remediation programs.

 

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  • A comprehensive audit of the clients Quality Management System can be undertaken to determine deficiencies.
  • Design and implementation of a Quality Management System to meet regulatory expectations.
  • Preparation of specific documentation required to support the Quality Management System.
  • Identifying continuous improvement opportunities within the Quality Management System.

 

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  • Auditing against EU GMPs, FDA GMPs, ISO 9001, ISO 13485, ISO 22716 and ISO 14644 standards.
  • Internal Auditing.
  • External Auditing of Finished Product Manufacturers, API plants, Warehouses, Suppliers, Service providers.
  • Preparation and inspection readiness for Regulatory Audits.

 

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  • Design and delivery of customised training programs and assessments covering GMP and Regulatory topics.
  • Design of workshops and presentation of industry case studies.
  • Development of company training plans.
  • Oversee and monitor deliverables of training plans.

 

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  • Management of quality improvement and document management projects.

 

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