Audits
Every audit is a systematic, independent and systematic process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Audits can be performed on-site or remote.
We offer the conduct of audits in the areas of GCP, GCLP, GLP, GMP / GDP, GVP, MDR / MPDG and IT.
Audit types include
We ensure full independence of our Experts of operational departments to be audited. Detailed and comprehensive audit reports are issued enabling the responsible management functions to understand the degree of compliance and to initiate any corrective and preventive actions.
Our senior Experts can also generate, manage and execute your annual audit programme by considering the importance of your clinical trials / preclinical safety testing for regulatory submissions, complexity of a system, implementation of new / revised procedural documents, changes in regulatory requirements or implementation of new software tools.
