Audit
Check your compliance and process compliance with external experts from QFINITY∞. In today’s highly diversified organizational reality, it is imperative that all parties involved in a business process follow the defined criteria. Regular audits provide confidence and help to identify weak links at an early stage.
GXP-AUDITS OF SUPPLIERS AND CONTRACTORS
„An audit is a systematic, independent and documented process to obtain audit evidence and to evaluate it objectively in order to determine the extent to which audit criteria are met.“ In qualification and validation processes, GxP-regulated companies can rely on supplier activities and documents. This is based on a relationship of trust between supplier and customer, which is based on in-depth knowledge of the supplier’s working methods and quality. This can be determined prospectively through an appropriate supplier assessment process. We support you in developing an audit strategy, as well as the planning and implementation of supplier qualification assessments, postal audits and on-site audits.
OUR SERVICE IN THE AREA OF AUDITS
- Mock Audits (FDA, EMA)
- Internal quality audits (QM processes and systems)
- Supplier evaluation (e.g. software, hosting partner, contract research organizations – CROs, outsourcing partners)
- On-site audits of potential partners (on-site audits)
- Repeat audits of partners who have already been audited (follow-up audits)
- Preparation of specification documents for the planning, execution and documentation of supplier audits
- Creation of benchmarking criteria for supplier selection
