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Auditing
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The rationale for auditing maybe for a number of reasons – there may be a routine requirement;
a regulatory requirement; a requirement to investigate a specific problem or a pre-inspection
audit preparing the site for an official inspection.
CRC has experience of conducting all these types of audits in a wide range of environments.
It commonly audits:
- Phase 1, 2 and 3 clinical trials
- Drug development and medical device trials in human and veterinary research
- In-house (sponsor) and investigational sites
- Third Party Organisation: feasibility and management
It conducts process, system and for cause audits.
Audits are conducted to the required standards – be that US Code of Federal Regulations (21 CFR),
ICH-GCP, ISO 14155, EU Directives or any other applicable regulations.
To discuss your company's auditing requirements contact us.
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