ELS Solutions provides assistance for the Certification of Good Manufacturing and/or Laboratory Practice processes, in accordance with the current regulations for the launch of its product in the Brazilian market. We are able to serve you at:
- Gap Analysis: comparative analysis of what is owned with what is necessary with the legislative scenario for obtaining GMP;
- Mock Inspection: preparation of pre-audits, for the standards met (contact our commercial team via email firstname.lastname@example.org);
- Support in ANVISA audits;
- Technical documentation assistance;
- Training of all employees to receive inspections;
- Advice on the treatment of post-audit Non-Conformities.
The Quality Management System (QMS) formalizes the process documentation, aiming at the quality of the entire production line. ELS Solutions creates an execution plan in order to guarantee a more efficient system, which meets the current legislation and the individuality of each company.
The INMETRO Certification of products or services, compulsorily or voluntarily certified, is carried out by independent product certification bodies (OCP), accredited by Inmetro, and ELS Solutions partners.
ELS Solutions provides support for your INMETRO certification process. We are able to serve you:
- Analysis of the mandatory INMETRO certification of the product of interest;
- Technical document evaluation for certification, when mandatory with the OCP;
- Support in the submission and monitoring of the INMETRO certification process;
- Advice on non-conformities presented after the audit.
The International Standardization Organization (ISO) aims to develop precepts that can be adopted by the world, with the aim of stimulating trade.
ELS Solutions is ISO 13485: 2016 certified, which establishes the fundamentals to guarantee the quality, safety and standardization of the entire medical device production cycle. We are able to serve you at:
- Technical document evaluation for certification;
- Support in the submission and monitoring of the ISO certification process;
- Advice on non-conformities presented after audit.