QUALITY ASSURANCE

GxP SOP & QMS Development - Improvement and Implementation Support;
GCP/GVP Internal & External Partner Audits - Inspections Support

…Quality is not an act, it is a habit
– Aristotle

It is the Policy of Creative Pharma & HR Services to achieve and maintain the highest Quality performance in providing its services. Highest Quality performance implies an explicit understanding of the Client, the Client’s needs and the service requirements. It also implies adherence to applicable national & international regulatory requirements and Quality and Information Security International Standards and a commitment in continually improving.

It is the objective of Creative PHS to embody its commitment to highest Quality into every aspect of its operations. This is sustained through the conservation of a corporate posture which embraces a climate of defect prevention rather that defect detection. Ηighest Quality performance also implies a level of employee achievement that reflects an unremitting pursuit for excellence. This performance is feasible through methodical training, encouragement for professional growth, motivation for Quality consciousness, prompt allocation of resources and structured process control and monitoring activities.

Towards meeting this objective, Creative PHS has developed, implemented and monitors a Quality Management System in line with the requirements of the International Standard ISO 9001:2015, as well as an Information Security Management System in line with the requirements of the International Standard ISO 27001:2013; both, also successfully certified for compliance with the Data Protection legal framework, including the General Data Protection Regulation (GDPR).

Embodying this Quality culture and with an extensive experience in the health sector and the pharmaceutical industry, as well as highly skilled professionals, Creative PHS provides Quality Assurance Services including: SOPs Development; GxP QMS Development, Improvement & Implementation Support; GCP/GVP Internal & External Partner Audits; GCP/GVP Audits & Inspections Support.

  • Preparation of Operating Procedures (incl. Standard Operating Procedures, Work Instructions, Forms, etc.)
  • Review of existing Operating Procedures for compliance with regulatory requirements, International Standards, given partnership contractual agreements, as well as for identifying areas of improvement.
  • Trainings of staff on SOP implementation
  • Set-up GxP QMS and related documentation as per corresponding requirements.
  • Review existing GxP QMSs for compliance with regulatory requirements, International Standards, given partnership contractual agreements, as well as for identifying potential areas of improvement.
  • Monitor GxP QMSs implementation.
  • Support various system implementation responsibilities and activities.
  • GCP/GVP Audits
  • System or process-specific
  • GCP/GVP Audits & Inspections
  • Support pre- and post-audit activities
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