Audits and Assessments
Do you want to know what the current status is of your organization or department? Is your organization part of continuous inspections?
Rescop can perform internal audits (specific area, process, manufacturing and/or system based) and external parties/supplier audits. Our auditors work with all current regulations (cGMP – cGxP).
To be successful during inspections/audits Rescop can perform Mock-audits onsite. The objective is to scan and monitor if your organization is audit prove by:
- Instruct and advice personnel how to act during questions auditor
- Scan and setup an efficient audit process flow (roles and responsibility)
- Scan and setup an efficient documentation retrieval flow (review, correctness and speed)
- Permanent Inspection readiness Program: Rescop can help setup an program to ensure your organization is ready at all times.
Senior Auditors have the following personal profile:
- Higher level education or Academic degree
- In-depth knowledge of regulations and quality standards
- At least 3 years auditing experience
- A broad and practical experience in regulated environments
- Pro-active and a high degree of flexibility/adaptability
- Excellent writing and verbal skills, English and Dutch
- Strong customer focus
The program for the Audit consists of the following activities:
- Preparation prior to the audit
- Collecting relevant information and analysis and judgment of the provided information during the audit
- Reporting results, conclusions and recommendations
- Further follow up, if requested
Our consultants have executed Facility, Utility, IT, and GxP audits. Moreover, we have consultants conducting GxP audits as parter with SQA.
We have executed several assessments on IT systems against GxP regulations and the GAMP5 guidelines for optimizing compliance purposes, like ERP, LIMS, MES and other GxP impacted IT systems. Besides GxP and GAMP5 impacted systems, we can also provide CISA certified auditors for more general IT systems.
All audits and assessments are executed in compliance with (if applicable):
Rescop is active in the following industries