Compliance Made Simple

Targeted and pragmatic implementation.

Innovation, Quality, Efficiency

Your business and quality processes seamlessly integrated.

Sustainable Profit

Quality by Design from the start.

Rely upon on our knowhow in the life science industry and customized solutions.

Quality Management System

Computerized Systems Validation

Information Security

Data Integrity

Quality Management – Operational Excellence

Your business and quality processes seamlessly integrated.

Applying current regulatory requirements whilst valuing your existing internal strategies and standards.

Internal Effects

External Effects

Computerized Systems Validation

Compliance with 21 CFR Part 11 and EU GMP Annex 11 during the entire life cycle.

We consult and support you with all topics and issues concerning the validation of computerized systems.

  1. Implementation of CSV-Projects
  2. Maintenance of validated sate
  3. Retirement of computerized systems

Information Security - QAS creates Awareness

Digitalization goes along with increased Cyber Security requirements.

You decide what is important to your and we deploy compliant with the standards.

General Information Security
Cloud Strategy for Life Science
Physical Security
Business Continuity Management  

  1. Analysis
  2. Conception
  3. Implementation

Data Integrity

Systems and Data Flows in perpetual Compliance.

With data Integrity Requirements applied right from the start.

Data Integrity by design

  1. Execution of Gap-Analysis
  2. Definition and Implementation of adequate measures
  3. Monitoring and Post-Assessments