Assuring quality, assuring integrity
Quality Management Systems (QMS) and Quality Assurance (QA) activities are essential for successful product development that complies with all GxP regulations. We offer Quality Assurance services that cover your needs from early development to post-marketing. Either through insourcing one of our QA specialists to your premises, or outsourcing specific tasks, a strategic partnership with LINK Medical will offer you services suited for your unique business needs.
A global team with local insights
Planning and carrying out clinical studies requires extensive documentation to ensure reliable results and compliance with local and international regulations. Our team of QA professionals have broad experience from across the life science and health sectors, giving them the competence required to:
- Plan and revise QMS documents, including standard operating procedures (SOPs), quality manuals and policies
- Perform a quality review of study deliverables to reduce the risk of invalid data
- Advise you on a risk-based quality level of your operations, and recommend implementation within your quality systems as required
- Develop and implement quality systems in pharmaceutical, biotech and medical device companies
- Provide training within GxP and related topics; from one single lecture to more extensive workshops and educational days.
To find out more about how our Quality Assurance services can ensure your documentation is fit for purpose and right first time, please contact Laila Agerholm, our Global Director, Quality Assurance & Compliance at: Laila.Agerholm@linkmedical.eu.
Alternatively, you can get in touch with one of our local QA professionals:
- Hilde Ringstad, Director QA and Compliance, Norway
Hilde.Ringstad@linkmedical.eu - Daniel Bjermo, Quality Manager, Sweden
Daniel.Bjermo@linkmedical.eu
Overview of Quality Assurance services:
Our Quality Management System (QMS) includes:
- Annual risk-based internal audit program
- Risk-based vendor assessment and management
- Quality Issue/complaint management
- Training Matrix and Training Oversight
- Validated computerised systems
We can be called upon for review of a single SOP or for setting up a complete quality system. We have specialized professionals with broad experience from quality assurance, quality control and quality advisor positions with health authorities and the international pharmaceutical industry.
Our services can be used in-house or at the customer’s premises,or with. subcontractors, We also take care of specific parts of a company’s processes. Let us advise you on the appropriate quality level of your operation.
Services within Quality assurance:
Audit services for:
- Regulatory inspection readiness and response
- Pre-audits and pre-inspections
- Investigational site audits
- GCP, GVP GLP, GMP and GDP compliance
- Self-inspections
- Suppliers/vendors
Study specific Quality and Compliance assistance:
- Compliance questions/issues
- Monitoring activities
- Investigational Product
- Study tools and documents
- Oversight visits
- GCP Training
Quality check of study deliverables including:
- Protocols
- Case report forms (CRFs & eCRFs)
- Clinical study reports
- Statistical analysis plans (SAPs)
- Study files (at a site and in-house)
- Data Management documentation
Other QA services:
- Training to prepare investigational sites for regulatory inspections
- Training in GxP, IMP handling and Quality management
- Developing and implementing quality systems in small pharmaceutical, biotech and medical device companies
Head of Department
