Whether in the pharmaceutical or medical device industry, quality assurance (QA) makes it possible to monitor, guarantee and demonstrate compliance with the quality rules implemented in the company, in order to meet the regulatory requirements in force and the safety and performance requirements of health products.
Numerous standards and regulations govern the development and manufacture of medicines and medical devices.
Thus, in a constrained and constantly evolving environment, oriented towards “patient risk”, it is imperative to structure oneself in order to be in control of one’s quality system.
We accompany all your projects related to the control of your quality management system (QMS) and its operational efficiency:
- According to ISO 13485:2016, ISO 9001:2015, GLP, GMP
- Gap analysis of the QMS
- Conformity of the QMS, according to the current standard
- Drafting, revision and updating of documents
- Risk assessment and management
- Carrying out internal audits, according to the current standard
- Support for the management of :
- Change Control
- Non-conformities and deviations
- Customer complaints
- Management of PQR (Product Quality Review)
- Management of Supplier Quality Assurance (SQA)
- Supplier audits
- Ensuring compliance of the SQA
A strategic support, according to the regulatory requirements in force, in close collaboration with your internal capacities (resources, sector of activity, size of the company, …) is set up in the respect of your internal processes and your project deadlines.
Our technical experts are able to establish a diagnosis of your Quality Management System according to ISO 9001:2015; ISO 13485:2016; GMP; GLP.
Our consultants are trained in the mastery of quality tools that will allow the implementation of a QMS tailored to your company.