Through our dedicated life sciences audit and consulting business Audithem, we support companies by providing them with auditors who have extensive expertise in and knowledge of the regulations and guidelines relevant to the pharmaceutical, medical devices, and cosmetic industries.
We ensure that our clients have in place the right systems and resources they need to bring safe and quality products to market by our offer of:
- Close and continuous support
- Appropriate and targeted advice
- Effective and easy-to-implement solutions
Audit and inspection readiness
Prepare client audits as well as global and corporate audits and inspections, including gap analyses, preaudits, personnel training, review of previous corrective-action-and-preventive-action (CAPA) plan, and implementation of defined and agreed actions.
Deploy risk-based approaches for prioritization, audit planning, and decision making.
Perform internal audits and supplier audits, including monitoring of CAPA plan implementation.
As part of various QA systems such as deviations, complaints, gap analyses, audits, and inspections, PLG supports the operational teams in implementations of CAPA plans and to determine and assess the effectiveness of the plans.
We turned to PLG two years ago for help with an audit and were very impressed by the organization’s professionalism and knowledge. The PLG auditor was one of the best we have ever worked with, across the 12 to 15 audits we undergo globally each year.
MD, Scientific Director Medwork Pharma Research and Consulting