e-Consulting

Audit & Certification

GMP
GDP
GVP
GLP
GCP
Others

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.

Audit Report
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Audit & Certification

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Guideline about Quality Audits Management

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Discover database of available reports

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– Our audit scope – 

GMP Audits (Good Manufacturing Practices)

  • 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).
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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.

GVP Audits (Good Vigilance 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
idmp medical products
Work Group

GLP & GCP Audits (Good Laboratory Practices & Good Clinical Practices)

  • 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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