Expertise
Quality control
Your challenges
Within the Quality Control laboratories, it is essential to verify and control all products delivered to the health market. From pharmaceutical products to medical devices, including biotechnologies, it is imperative to implement these controls in order to guarantee the quality, effectiveness and safety of the products delivered.
Numerous standards and regulations govern the development of analytical methods and the commissioning of equipment. Whether for physico-chemical, microbiological or mechanical tests, it is imperative to qualify and validate all the analytical methods and equipment in order to be in control of your processes.
Our support
With our expertise and know-how, we are able to support you in the development of your methods, the management of your equipment qualifications while maintaining your quality level within the laboratory.
Our consultants are trained in the mastery of analytical techniques, Qualification / Validation tools and Lean management, which will allow you to maintain a level of excellence within your Quality Control laboratory.
We accompany all your projects related to quality control on :
- Scientific analyses;
- Analytical developments ;
- Method developments ;
- Analytical transfers ;
- Method transfers ;
- Project management ;
- Lean management.
According to regulatory standards: GLP, ISO 17025, ICH and pharmacopoeia
Our solutions
A strategic accompaniment is set up on your various subjects
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- Review of batch records (DDL)
- Continuous improvement of the laboratory – Operational excellence
- Conduct and follow-up of stability studies
- Management of your stocks
- Participation in regular quality control activities
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- Definition of a complete URS
- Construction of risk analyses
- Definition of the strategy and experimental plan
- Drafting of all test documentation (protocols, raw data sheets, …)
- Management of validation hazards (incidents, non-conformities, deviations)
- Reprocessing and interpretation of all results
- Realization of statistical studies
- Writing of validation reports
- Management of all associated quality tools (Change Control in particular)
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- Project management according to V-cycle methodology;
- Definition of a complete URS;
- Construction of risk and impact analyses;
- Definition of the strategy;
- Drafting of all test documentation (protocols, raw data sheets, …) IQ, OQ, PQ ;
- Follow-up of installation / commissioning of equipment (FAT/SAT);
- Follow-up and maintenance of supplier exchanges;
- Management of qualification hazards (incidents, non-conformities, deviations);
- Reprocessing and interpretation of all results;
- Writing of qualification reports;
- Management of all associated quality tools (Change Control in particular).
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- Project management according to V-cycle or AGILE methodology;
- Definition of a complete URS;
- Construction of risk and impact analyses;
- Classification of your systems according to GAMP 5 ;
- Definition of the Data Integrity strategy;
- Drafting of all test documentation (protocols, raw data sheets, …) IQ, OQ, PQ ;
- Follow-up and maintenance of supplier exchanges;
- Management of validation hazards (incidents, non-conformities, deviations);
- Reprocessing and interpretation of all results;
- Writing of qualification reports;
- Management of all associated quality tools (Change Control in particular).
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