Audits

NOVE OBAVIJESTI

Poštovani klijenti, obavještavamo Vas da od 19.10.2020., radi primjene mjera za sprječavanje širenja zaraze SARS-CoV-2 virusom, umjesto kontaktnih seminara svi seminari će se održavati kao online seminari. Molimo Vas da pogledate novi, izmijenjeni raspored svih seminara, a za dodatne informacije slobodno nas kontaktirajte. 

Usluge poslovnog savjetovanja: uvođenje sustava kvalitete i drugih sustava upravljanja (ISO standarda); usklađivanje sa zahtjevima dobre proizvođačke, distribucijske, laboratorijske ili kliničke prakse (GMP, GDP, GLP, GCP); izrada dokumentacije o proizvodu - PIF („Product Information File“) za kozmetičke proizvode; dopuna tehničke dokumentacije za medicinske proizvode u skladu s novom uredbom; izrada kliničkih evaluacija za medicinske proizvode; podrška kod validacije računalnih sustava; validacija excel predložaka; statistička obrada podataka; stručni prijevodi (iz područja GMP, GDP, GLP, GCP, ISO); te provedba audita i dalje su dostupne - na daljinu (on-desk).

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An independent audit (assessment, inspection) is a tool that will help you to evaluate objectively the current status of your company, laboratory, or institution in compliance with applicable regulatory requirements and standards.

SUPERA KVALITETA provides internal auditing services for your company, laboratory or institution, as well as audits of your suppliers, contracted manufacturers, laboratories or partners. 

We perform audits in an open and positive manner, in a time and volume appropriate to your needs, with assured objectivity, experience and confidentiality. Upon completion of the audit, we submit the Audit Report.

We offer the possibility of monitoring the results of the audits performed and for resolving non-conformities (discrepancies) observed. We produce regular periodic reports that include the status of implementation and the checking of corrective and preventive actions efficiency to ensure that all audits are properly completed.

To API manufacturers and wholesalers we offer an independent audit. We sell the audit report to partners / customers / suppliers of those manufacturers or wholesalers. This way manufacturers and wholesalers reduce their costs, optimize their time and reduce the pressure / stress that comes with the auditors from different companies, who conduct the same type of audits. On the other hand, their partners / customers / suppliers also reduce their costs and optimize their time, because they can use the time spent on auditing and writing reports for other business activities.

SUPERA KVALITETA  performs:

  •  Third-party audits

We perform audits of your suppliers, contracted manufacturers, or laboratories in compliance with applicable regulatory requirements and standards. 

  • Internal audits

We perform internal audits in your company, laboratory or institution in compliance with applicable regulatory requirements and standards. 

  • "Mock Regulatory" audits

Clients receive practical simulation of regulatory inspection and advices on how to manage during regulatory inspection and how to present inspected areas.

  • "Benchmarking" audits

We help you to evaluate the system in place in your company in regard to others in the market and to give you practical recommendations on how to improve the system.

  • "Due Diligence" audits

We perform a complete and detailed assessment of compliance with the regulatory requirements and standards of the company or project of your interest.

According to your needs and interest we organize and perform in-house trainings for internal auditors.