At Azierta, we offer a worldwide audit service. With our teams of local experts, we enable companies to optimise their resources, improving the time and scope of each audit:
Collection of information and historical data to customise each audit according to the needs of our customers.
Detection of deviations in the audited process.
Preparation of a preliminary report at the start of the audit and delivery of a detailed final report.
Review and monitoring of the CAPA plan.
Design of a classification system and management of contractors based on risk to prioritise the audits and other assessable activities.
Audits for preclinical development laboratories focused on research.
Audits for CRO.
Sponsor of clinical trials.
Other Audits
Clinical Analysis Laboratories Audits
Audits of the quality management systems of Clinical Laboratories based on the requirements of standard UNE-EN-ISO 15189:2013.
Medical Cannabis Audits
Audits of cannabis cultivation plants, manufacturers of their derivatives for medicinal purposes, and their warehouses and distribution centres.
Internal Audits
We put our experience and knowledge at the service of the industry to periodically examine its quality system and verify compliance with the standard.
Our customers have the opportunity to identify areas for improvement to optimise their efforts and resources.
Audits for Compliance of Medical Devices
Audits of the quality management systems of manufacturers of medical devices based on the requirements of standard UNE-EN-ISO 13485:2016.
Data Integrity Audits
In the audit of this system, we assess the level of data integrity assurance at every stage of the process, verifying compliance with ALCOA principles in the management of manual and electronic records.
“Azierta Audit & Certification is your trusted partner to guarantee high quality and ensure regulatory compliance”.
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