Quality and Compliancy

Validation and assurance of digital systems and continue to control your computerization. Whether your organization is large or small, its distinctive requirements provided in a difficult and uncertain process. We can provide some services for the most common and complex issues related to validation and assurance of your (ERP) systems. Our services include: 

	(ERP) System Validation
	Training and workshops

(ERP) System Validation

We offer a package of validation work, according to GAMP and ISPE * ** guidelines, to achieve that your systems comply with regulations such as FDA (Food and Drug Administration), GxP OECD (Organization for Economic Co-operation and Development). Besides carrying out validation during the implementation validation (prospective validation) of already implemented systems can be performed (retrospective validation).

GAMP* (Good Automated Manufacturing Practices) is a guideline for validation of automation systems. The aim of GAMP is to assist suppliers in the pharmaceutical and related industries to achieve validated automation.

ISPE** (International Society for Pharmaceutical Engineering) is the world's largest non-profit organization focusing on educating and improving professionals working in the pharmaceutical industry.

Training and workshops

To validate your information under certain guidelines, it is necessary to have knowledge of and understand the use of these guidelines. We provide various trainings and workshops especially for engineers, project managers, process engineers, quality engineers and others who come into contact with this subject: 

	GAMP®5 Overview
	GAMP®5 CSV – 2days Workshop
	ERP Validation Course

These services will be provided together with our partner ComplianceControl.