- 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.
Audit & Certification
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. Our service ensures the comfort and ease of the process managed by a single representative: Azierta.
ABOUT COMPANY
Scheduling of audits:
“Azierta Audit & Certification is your trusted partner to guarantee high quality and ensure regulatory compliance”.
We establish a close relationship with our customers based on the commitment, transparency and availability of our experts.
Our audit scope
GxP Audits
Clinical Analysis Laboratories Audits
Audits for Compliance of Medical Devices
Medicinal Cannabis audits
Data Integrity Audits
Internal Audits
GxP Audits
High-quality audits for GxP requirements that assess the level of compliance and implementation of customers and/or suppliers quality systems and outsourced activities.
GMP Audits
- Supplier audits: Manufacturers of APIs, primary and secondary packaging materials, excipients, intermediate product, finished product.
- Audits for manufacturing laboratories (CMO).
- Audits for testing laboratories (quality control).
GDP Audits (Good Distribution Practices)
Audits for logistics operators (warehouses, distribution centres and carriers)
- API Distributor
- Excipient distributor
- Intermediate product or finished product distributor
- Intermediate warehouses
GCP Audits (Good Clinical Practices)
- Audits for CRO.
- Sponsor of clinical trials.
GLP Audits (Good Laboratory Practices)
- Audits for preclinical development laboratories focused on research.
GVP Audits (Good Pharmacovigilance Practices)
- Internal audits of Pharmacovigilance Systems
- Support and assistance in inspections issued by the health authorities
- External audits of subsidiaries, partners and CROs
- In-person/remote 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.
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.
Medicinal Cannabis audits
- Audits of cannabis cultivation plants, manufacturers of their derivatives for medicinal purposes, and their warehouses and distribution centres.
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.
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.
Supplier Audit Reports
Discover our extensive database with available reports. Our audit reports have been performed by our highly experienced local auditors with suppliers worldwide. Save time and optimise resources.
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