QUALITY SYSTEM (BPF, GMP US FDA, INMETRO’s ORDINANCE 54/2016, ISO 13485 AND ISO 9001:2015)
The Passarini Regulatory Affairs offers various services of audit in quality management systems in Brazil and abroad, even because it is recommendable that the manufacturers audit with frequency their quality systems to ensure compliance and attendance to the health standards determined by each country where your product is being commercialized. The absence of periodic audits results in low quality products and even loss of certification or improvement of the process.
With the intention to better attend our customer, we count with a staff of auditors able to perform audits Passarini Regulatory Affairs Brazil, audits of their systems to ensure compliance with the rules of the Quality System US FDA, Directives for European Devices, PAL of Japan and the regulations of the Canadian Medical Device.
The Passarini Regulatory Affairs Offers Various Audit Services For Quality Management Systems In Brazil And Abroad:
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- Diagnostic audits – It is recommended to be performed an audit before the inspection that will be performed by the certification body or the Ministry of Health, with the aim to ensure that the quality system truly meets the requirements that will be checked by the auditor body/supervisory. The auditors of the Passarini Regulatory Affairs will ensure that your company is aware of all non-compliances (NC) found and suggestions for corrective actions to achieve success in the audit to be carried out by the Auditor Body.
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- Complete or partial audits – The ISO 13485 and the FDA QSR (21 CFR Part 820) requires that the manufacturers performs a periodic internal audits on their quality management systems. The Passarini Regulatory Affairs provides internal audit services that allows an independent review of its entire system of quality.
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- Audits for analysis and failures – This is an audit, in which we determine your current level of compliance with the regulations of the appropriate quality as Brazilian Good Manufacturing Practices (BGMP), GMP US FDA, ISO 13485, PAL Japan and/or Canadian Regulations. The failure analysis is normally performed before a system is implemented to determine areas of deficiency.
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- Subcontracted or suppliers’ audits – Critical suppliers must be “controlled”. This is not just a good business practice, but often it is also a regulatory requirement. The Passarini Regulatory Affairs can perform audits on-site in yours suppliers to ensure that the activities are being executed within the standards required.
