Auditing Services - GXP Engaged
GXP Engaged Core Services
- Evaluation, review, setting-up and implementing QM systems in client companies, including writing or support with writing SOPs
- Independent full or partial QM or QA coverage of client companies who need additional resources in QM/QA
- Definition of and/or execution of QM and auditing plans for clinical studies
- Conduction of audits for clients, covering all areas of clinical studies
including ...
- critical suppliers
- investigational sites
and key activities such as ...
- investigational site study management
- clinical monitoring
- safety management
- regulatory affairs
- data management
- biometrics
and essential documents such as ...
- protocols
- informed consent documents
- patient information documentation
- investigator files
- trial master files
- tables and listings
- clinical study reports
The QM team involved in execution of GXP Engaged Auditing Services contracts has provided this type of service for small, mid-size and large companies in the pharmaceutical, biotechnology, medical device and related industries, since 2003.
Please refer to the "Experience" section of this Web site.