Quality Management

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Quality Management

Steps of QMS Implementation

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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.Auditor image


  • 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.


  • 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.


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


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