The agile qualification and validation strategy according to cGMP can be implemented independent of the product and the connected validation strategy. In the age of „Pharma 4.0“ it is complex and difficult to transfer projects into a holistic planning conforming to the requirements of the regulated industry.
AQV contributes to transparency on the part of the supplier as well as the operating company. Requirements, progress and challenges are recorded in a regular and clearly visible way. Results and functionality of the automated manufacturing process are continuously delivered and assessed.
Requirements for the automated system, plans and procedures are not set in stone. They are adapted continuously and in detail.
AQV does not reduce the complexity of the validation, but structures validation in smaller, less complex elements. This will ensure success at the end of the project life cycle.