Auditing & Assessments
The third pillar of Rescop’s Consultancy Services focuses on comprehensive audits and assessments. These services enhance our core offerings in Validation & Qualification and Quality Management but are also available as independent, standalone solutions. With extensive experience in the Pharmaceutical and Medical Device industries, our experts are highly trained to conduct thorough assessments, ensuring that your operations align with regulatory standards and industry best practices. Rescop’s audits provide actionable insights, helping to maintain compliance, optimize processes, and uphold the highest quality standards.
Our Core Business for Auditing & Assessments Services
GAP Assessments
- Comprehensive GAP assessments to identify and address compliance gaps in CSV (Computerized System Validation), process validation, and Quality Management System (QMS) requirements. Each assessment provides actionable reporting for improved compliance and quality standards.
Health Authority Inspection & Notified Body Audit Services
- Full support for Health Authority inspections and Notified Body audits, including thorough preparation, execution, and response to regulatory observations. Our services encompass training personnel, preparing sites for inspection, and providing robust audit hosting and follow-up.
Audit Services
- Extensive QMS audit services for critical suppliers, ensuring compliance and quality from IT software providers (SaaS), IT infrastructure & platform providers (IaaS and PaaS), and GxP service providers. Our audits provide detailed evaluations to enhance supplier quality and adherence to industry standards.
For more information on best practices and industry standards, refer to:
- FDA Computer System Validation Guidelines
- European Medicines Agency GxP Guidelines
- International Society for Pharmaceutical Engineering (ISPE) GAMP Guidelines
By aligning with these guidelines and leveraging Rescop’s expertise, you can ensure optimal compliance, quality, and operational efficiency across your business processes.
Sourcing: Supplier of interim personnel to support your Audit Operations