QiP GmbHThe audit: No problem if you are prepared.
What is it about:
An audit (or audit) examines whether the processes meet all relevant legal requirements and guidelines as well as valid standards. Audits are carried out by specially trained people (auditors).
As part of quality management, the audit has the character of a review and provides evidence of compliance with the requirements.
Use our help to avoid problems!
QiP GmbH is not a “notified body” or a commissioned FDA inspector. We therefore do not carry out these audits/inspections, but we can prepare and accompany you so that they can be successfully completed to your satisfaction.
- External audits, e.g. system audit, supplier audit, audit of contract manufacturers
- Internal audits
- Mock audits (e.g. to prepare an FDA inspection or certification audit according to ISO 13485)
- Co-monitoring
- Document audits, e.g. QM manual (QMH), technical documentation (TD), CTD dossier, approval documentation, etc.
- Audit of clinical studies, e.g. Trial Master File (TMF, study folder), study documents, on site (test centers)
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