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.