Service and methodology

We provde the following services: Progress or post implementation project audits Development and implementation of customer internal audit processes Architectural audit with focus on validation, reliability, security, integrity and service orientation.

Audits are performed against defined requirements. These can be:

• Customer's internal standards and guidelines

• Regulatory requirements as compliance to Good Practices as manufacturing, clinical or laboratory practices (GMP, GCP, GLP)

• Benchmarks of other, related industries where available

 
Audit questions to verify fulfilment of requirements will be defined before any audit is conducted. All questions will be open to management
and auditees to foster an open atmosphere. The main part of the audit is the collection of evidence of fulfillment of the requirements. Evidence
is based on documented proof, on analysing work done, and on interview techniques. A detailed deviation report will be provided in case of
compliance with regulations as Good Practices (GMP, GCP, GLP) is audited. In other cases, deviations are aggregated to findings, which are
supported by observed evidence and analysed for root cause as far as possible. The findings are the basis for corrective actions and future
improvements. An executive summary will answer the questions of the management.