Quality Assurance

Dr. Manfred Koehler GmbH has established an internal quality management setting, which guarantees for all projects full compliance with scientific and regulatory quality standards, as required by GCP and ICH guidelines as well as by CFR 21 Part 11 standard.

Our Quality Management Board (QMB) ensures that standards, processes and personnel are in place and functioning properly to achieve consistent and effective QA performance by

• Developing and implementing Standard Operating Procedures (SOPs)
• Employee training
• Undergoing audits by independent audit firms/institutes.

Activities are controlled by a comprehensive library of written SOPs, which are available for inspection by our clients on request. These SOPs cover all aspects of our operations. All projects are conducted in compliance with Dr. Manfred Köhler’s or the client’s SOPs.

Dr. Koehler’s biostatisticians and SAS programmers follow SOPs to ensure the consistency and integrity of study results. Programming standards as well as a version control system assure the programming quality. We have a multi-stage procedural and scientific QC process consisting of the following elements:

• Data handling plan
• Statistical analysis plan
• Version control system
• Programming guidelines
• Program validation
• Double programming of analysis datasets
• Output review

Dr. Manfred Koehler GmbH undergoes regular audits by sponsors/clients. The resulting audit reports confirm the excellent scientific and regulatory quality of our work.