Quality Management

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We provide the following services:

Quality Management System (QMS)

• Establishment, implementation and maintenance of your organization’s QMS in compliance with ISO standards.
• Current stage assessment and gap analysis of the QMS, followed by action plan to ensure compliance.
• Management and staff training.
• Corrective and preventive action (CAPA) program development.
• Management Review planning, performance and presentation of a detailed report.
• Risk assessment of the organization’s and/or laboratory’s activities.
• Setting and measurement of the organization’s Quality Indicators.

 Preparation and revision of QMS documentation

• Organization and/or laboratory policies in compliance with requirements.
• SOPs and processes.
• Validation protocols and reports.
• Quality records.

GMP / GLP

• Gap analysis to assess the level of compliance with regulations.
• Establishment or upgrading of GLP/GMP.

Quality Control (QC) program development

• Developing and setting-up laboratory QC program.
• Implementation and maintenance of the QC system.
• Performing self-inspection.

Auditing

• Internal audits to ensure your organization’s compliance with GMP and/or ISO requirements.
• Audit findings are presented and communicated in a comprehensive audit report.
• Preparation for external audits.

Validation

• Development and execution of validation protocols.
• Development or revision of validation plan.
• Analytical method validation support.
• Process validation support.