Quality assurance and validation

In DI-Teknik, we focus on quality assurance and validation. We want to ensure high uptime and the right product quality in the manufacturing companies we service. Therefore, we comply with quality requirements that support the requirements of the ISO Standard and GAMP5 Guidelines, when we deliver automation to our customers. This ensures that design, functionality, and requirements, are thoroughly documented and tested before commissioning.

GAMP ® (Good Automated Manufacturing Practice)

One of the core principles for GAMP® is that the quality cannot be tested in a lot or product batch alone, but must be incorporated into each stage of the manufacturing process. It is a risk-based approach to compatible GxP Computerized Systems that provides a framework for the risk-based approach to computer system validation, where a system is evaluated and assigned a predefined category based on the intended use of complexity.

As a result, GAMP covers all aspects of production; From raw materials, plants, and equipment to staff training and hygiene. By properly applying the GAMP standard, companies operating in regulated industries can ensure the required quality and safety. They can also reduce the time and cost of troubleshooting and auditing as well as any risk of withdrawal of the product.

In March 2008, the International Society for Pharmaceutical Engineering (ISPE) issued the global release of GAMP5. A risk-based approach to compatible GxP Computerized Systems. Compared with previous GAMP versions, GAMP5 has a greater focus on risk assessment, quality management, and validation.

Learn more about other certifications in DI-Teknik below: