Quality Management

How can occured failures be avoided in the future? Start to treat the root cause, not the...

How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...

Nowadays all regulatory authorities focus on data integrity and have their own data integrity...

The introduction of a LDMS has an extremely positive impact on the efficiency and quality of...

Introducing and implementing an EBR system requires systematic analysis, definition and...

Various different aspects must be considered in order to transfer documentation management,...

This download covers all aspects you have to consider when transferring!

incl. an...

This pdf download shows how you can establish an effective CAPA system, which interfaces there...

In this pdf download you'll find answers on how deviations are defined, what must be observed...

This download shows you procedures you can implement now that ensure the successful management...

The deployment of human resources must be carefully planned and organised. In order to assist...

This sample document defines framework conditions and processes between contract givers and...

SOP "Technical Agreement and Delimitation of Pharmaceutical Responsibilities"
Standard...