OUR SUPPORT to your compliance
Our Quality Assurance team has always had a mission: disseminating the culture of quality within corporate environments. By studying a completely customized solution totally based on the needs and requirements of the company, we are keen to support its quality processes up to the total outsourcing of the Quality System, allowing the company to focus on its main business.
A QUALITY SYSTEM built
UPON client's NEEDS
Our Quality Assurance team is able to support you during the various stages of the quality process, from project management and training to development and results. The team will work closely with the client to set up a quality assurance and control plan, with an eye to keep systems updated with the latest regulations, GxP, and industry standards.
Un supporto continuativo su tutto il lifecycle management
We work to ensure the compliance of our client companies with quality standards requested.
In detail, we offer support in the following areas:
- GxP quality system design and compliance evaluation
- Design, implementation and maintenance of QMS in accordance with ISO 9001: 2015, ISO 14155: 2020 and ISO 13485: 2016
- GAP analysis & risk assessment of existing systems
- Management of Change, Non-Conformity and CAPA
- Management of the life cycle of documents / modules and SOPs of GxP quality systems
- Support during inspection and customer / third party audits
- Internal and supplier Audits (System Audits)
- Remediation plan for EU&US GMP
- Batch record review and PQR drafting
1. Gap Assessment
A first initial assessment to get to know your real needs and build a tailor-made package in synergy with you.
2. CONSTRUCTION OF YOUR "QUALITY BLISTER"
Design of your customized solution in the field:
Quality System for PRODUCTION PROCESSES
From setting up to maintaining the quality system
Quality System for CLINICAL STUDIES
From start-up to study development
Are you interested?
Discover the opportunity to activate your dedicated package.
Can I contact JSB to outsource audits to suppliers?
Yes, you can, JSB has internal auditors who can guarantee the execution of audits in the GxP area.
Can JSB support me for the implementation of a quality system?
Yes, it can, thanks to projects such as Quality Blister, JSB is able to build your quality system at 360 degrees and guarantee its maintenance over time.
Can JSB provide industry training?
Yes, it can, our “The Essential project” was born precisely to meet the need for a training package based on the necessities of your company, which we are able to identify with an initial Gap Analysis.
La nostra soluzione per una formazione completa e personalizzata in ambito GxP.
Il tuo personale, la nostra formazione.
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