In all industries guidelines and/or regulations apply to ensure that the quality of products and/or services are guaranteed. Performing an internal regular audit is a way to validate if your company is still working according to the guidelines and/or regulations. But also control of suppliers is validated with an audit.
Within PQM Consultancy extensive experience is available to perform audits at different levels (e.g. ISO, GxP, Excipients, quality, CISA, Food, Medical Device).
Support can be provided in the following areas:
- Development of audit programs, based on a risk-based approache, and audit reporting
- Perform internal audit / self-inspection
- Executing external audit of your service provider (s) regarding raw materials, excipients, materials, services (including outsourcing ICT, maintenance, testing laboratories)
- Preparation and/or monitoring of audits, e.g. (government) Inspection
- On-the-job or class room training for your employees