Auditing & Assessments
The third pillar of Rescop’s Consultancy Services are related to audits and assessments. These services can be an integral part of the Validation & Qualification or Quality Management Services that we provide but may be as well deployed as a service on its own. Our experts are adequately trained and can look back on many years of experience in Pharmaceutical and Medical Device industry.
Our core business for Auditing & Assessments services are:
- Execution and reporting of GAP assessment with regard to CSV requirements, process validation requirements, QMS requirements.
Heath Authority inspection / Notified Body audit services
- Preparation on, execution of and responding to a Health Authority Inspections / Notified Body audits (e.g. training personnel, site preparation of inspection / audit incl. the hosting thereof, responding to observations)
- Preparation and execution of QMS Audits of your critical suppliers such as but not limited to IT Software Providers (e.g. SAAS), IT infrastructure & Platform providers (e.g. IAAS and PAAS), GxP Service providers.