QV-Compliance A/S has many years of experience with quality management within the pharmaceutical industry and other regulated industries. We can assist you with:

  • Coordinate and perform qualification activities
  • Act as QA approver of quality documents
  • Nonconformity handling
  • CAPA handling
  • Change management
  • Audit of quality management systems
  • Risk management
  • Training sessions
  • Writing SOP’s
  • Good documentation practice
  • Data integrity
  • Quality metrics
  • Quality culture
  • Establishment of quality politics
  • Development of elements of a quality management system

We can work with within your quality management system – or we can assist you with the development of a new quality management solution. We can perform and coordinate qualification activities during a project such as writing validation master plans, validation plan and qualification protocols. The V model approach will normally be used for the whole validation package for equipment or process, see V-model. Our specialists have documented experience from design/requirement specification to performance qualification or process validation (URS, IQ, OQ, PQ and PV).
Furthermore, we can supplement your quality organization temporarily with manpower, e.g during a project peek or during production.

Specialists in QV-Compliance A/S are trained in ISO 9000 based quality systems and are up to date with GxP requirements within the field of quality.