In EN ISO 9000:2000, Quality Assurance is defined as "part of quality management focused on providing confidence that quality requirements will be fulfilled". Quality Assurance is the Process wich ensures that a product reach a determined Qualityniveau. The Product itself can be materiel, a service or a procedure.

We are a experienced service provider in the areas Pharma and Medical Devices. CFR 21 Part 11 and GMP are well known therms for us.

We would be pleased to support your Quality Assurance with follow Documents and Services:

• Qualitymanagementplans
• Documenttemplates
• Testplans
• Testspecifications
• Reviews
• Codeinspections
• Validations
• and many more