Quality Management System (QMS)
At HiTech Health, we specialise in the generation, and implementation of robust Quality Management Systems (QMS) that ensure the highest level of quality and compliance. Our expertise spans QMS systems across a diverse range of product types including small molecules, biologics, advanced medicines (cell and gene therapies) and vaccines.
A Quality Management System (QMS) refers to the policies, processes, procedures, and resources that ensures medicines are consistently developed, manufactured, tested, stored, and distributed to the required quality standards. A well-designed and maintained QMS not only ensures compliance but also strengthens operational performance and supports scalability. HiTech Health provides end-to-end support in establishing and maintaining QMS solutions tailored to your organisation, including:
- QMS system generation suitable for your product needs
- End-to-end QMS from raw materials through to distribution
Detailed QMS development and support can be provided including:
- Quality manuals and policies
- Standard Operating Procedures (SOPs)
- Vendor management programs
- Quality Audit system
- Training
- Risk Management
- Document control and lifecycle management
- Change control and deviation management
- Quality Technical Agreements
- Generation and implementation of a Manufacturer’s / Importer’s Authorisations (MIA) and Wholesaler Distribution Authorisations (WDA)