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 QA 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 - Randi Riise, Quality Manager, Norway
Randi.Riise@linkmedical.eu - Luka Lauridsen, Quality Manager, Denmark
Luka.Lauridsen@linkmedical.eu - Daniel Bjermo, Quality Manager, Sweden
Daniel.Bjermo@linkmedical.eu
Overview of Quality Assurance services:
Planning and revision of QMS and QMS documents including:
- Quality Manuals
- Policies
- SOPs
- Work Instructions
- Templates
- Forms
- Checklists
Audit services:
- Regulatory inspection readiness and response
- Pre-audits and pre-inspections
- Investigational site audits
- GCP, GVP and GDP compliance
- Self-inspections
- Suppliers/vendors
Quality check of study deliverables including:
- Protocols
- Case report forms (CRFs & eCRFs)
- Clinical study reports
- Statistical analysis plans (SAPs)
- Data management documentation
- Study files (on-site and in-house)
Training and lecturing services:
- Drug development
- GCP
- GDP
- Quality management
LINK Medical Quality Management System
We work to the highest quality requirements across numerous GxP and ISO standards for Medicinal and Medical Device clinical studies, and our QMS includes:
- Annual risk-based internal audit program
- Risk-based vendor assessment and management
- Quality Issue/complaint management
Head of Department
