QA and Audit
QV-Compliance A/S has many years of experience with quality management within the pharmaceutical industry and other regulated industries. We provide Lead auditors within ISO 9001 and ISO 13485 and can assist by performing Internal audits as well as Supplier audits.
Futhermore, 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 (Trained Auditor within ISO 9001 and ISO 13485)
- 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 or the risk-based approach will normally be used for the whole validation package for equipment or process, see V-model or the risk-based approach. 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.
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