QUALITY management system (QMS) and quality ASSURANCE (QA) SERVICES for medicines, medical devices and IVDs
Quality management is an absolute necessity to survive as a pharma, medical device (MD) or in vitro diagnostic medical device (IVD) company today. Inspections are carried out by the competent authorities to monitor compliance with quality standards.
If you are in need of consultation regarding quality management systems or quality-related processes, Medfiles’ dedicated Quality Assurance Team is happy to help you. The team has expertise in quality management systems of clinical trials (GCP), pharmacovigilance (GVP), good manufacturing practice (GMP), medical devices and IVDs. Additionally, we offer GxP training and consultation, as well as support in writing SOPs and quality instructions.
By choosing Medfiles you will also receive GDP-compliant expertise and extensive knowledge of pharmaceutical wholesale activities. Our legalised licensed pharmacists can act as responsible pharmacists of pharmaceutical wholesale in Finland, including short-time assignments.
Audits
We can support you with GCP, GDP or PV audits by providing audit services, assistance and consultation. Medfiles has a pool of internal qualified GxP auditors, available to act as lead auditors or help you as an expert.
Our experienced auditors offer a range of audit services, including:
- GCP site and vendor audits
- CRA audits
- Pharmacovigilance audits
- MD and IVD quality management system pre-audits
Quality at Medfiles
The entire Medfiles staff is dedicated to maintaining quality standards and undertake a specific and personalised training program. We are always up to date with GxP requirements and aware of coming changes, taking pride in delivering the best quality to our clients.
To ensure a high standard of quality, we organise regular GxP (including GVP, GCP, GDP) training for our staff related to their responsibilities.
Our quality system
All operations of the business units are based on standard operating procedures – i.e. the SOP system and company policies. Medfiles quality system is maintained, developed and updated in accordance with GxP guidelines and applicable regulatory requirements.
We have an electronic validated quality management system (QMS) in place including SOPs, deviation and complaint handling and change control. Our harmonised quality system ensures that quality work extends to all our operations. In this way, non-GxP functions are also within the scope of the system according to quality standards.
Our quality operations and quality management system are regularly audited by the authorities and our clients.
quality assurance (QA) Team
The experts within our Quality Assurance Team take care of our quality system and collaborate with unit experts to ensure the delivery of high-quality work to our clients.
Our Head of QA and QA Managers with GxP experience make sure that the requirements of the regulations are met.
The QA managers ensure that the monitoring of GxP requirements remains in expert hands. In addition, we have a QA coordinator taking care of the daily operations.
