Quality and Compliance
Trusted quality and passion.
Quality delivered, quality assured
TFS HealthScience ensures data integrity and high-quality services are provided to all customers. Quality and Compliance provides well-trained experts to support and guide you through global compliance challenges.
We do this by operating Quality and Compliance as an independent unit reporting directly to the CEO. The team is dedicated and vigilant so customers can rest assured that their clinical trials, projects, and related services are planned, conducted, and reported in compliance with relevant global regulatory requirements, guidance, and organizational Standard Operating Procedures (SOPs). To assure the compliance of processes and the integrity of trial data, regular risk-based internal systems audits are carried out using the Corrective Action Preventive Action (CAPA) process, where the team performs a risk assessment and the RCA (Root Cause Analysis) to ensure appropriate and robust CAPA are tracked to completion.
Our commitment to Quality and Compliance
Compliance is a key priority across the TFS business, and the quality delivered in all of our services is of utmost importance. Our customers, healthcare professionals, and patients trust that we consistently deliver the expected high-quality standards.
External focus
Our goal is to differentiate ourselves through Clinical Research Excellence, providing excellent and consistent fulfillment of customer expectations and delivering high-quality solutions to the biopharma industry—getting it right the first time, every time.
Responsible behavior
We are driven by respect for our customers, patients, and each other, always performing with uncompromising integrity. We deliver valuable people-based solutions and quality services in compliance with regulatory requirements and local health authority expectations.
Culture drives quality
We are dedicated to building high-performing teams of engaged and knowledgeable individuals in which every employee contributes to a culture of learning and continuous improvement through our Quality Objectives and our Quality Management System.
Quality creates value
Optimizing processes, managing risks, increasing efficiency, and delivering high-quality services creates value for our customers and generates business opportunities to achieve a competitive advantage in the market.
Quality and Compliance integration with
Training and Legal
Quality Management
Quality management at TFS is integrated at the project level and ensured via in-process controls, formal Quality Control (i.e. Monitoring Visits, Trial Master File check) and processes by project management. The team manages the Quality System, Quality Issue and CAPA process. They are responsible for ensuring the Computer System Validation (CSV) process is followed and compliant with regulations. They also conduct risk-based audits including internal systems, project audits, and vendor audits to ensure equivalent standards.
Training
The TFS Learning Management System (LMS) offers a robust platform for training and maintaining training records for all relevant TFS employees. Training is customized according to an approved training matrix that includes country-specific regulatory training.
Corporate Legal
Corporate Legal at TFS has an extensive experience including data protection and compliance areas and works on customized flexible, practical and high-quality legal support.
Working with TFS Quality and Compliance
Best practice, worldwide
Our Quality Management System is based on best practice quality systems and includes all ICH GCP as well as global requirements. The system includes a series of controlled documents falling into two categories: quality management system documents for all GXP-related work (Quality Manuals, Policies, SOPs, work instructions, supportive tools, and guidelines) and business operating procedures.
Complete integration
Ability to work with other SOP systems (e.g., other CRO or Sponsors) in cases where the sponsor’s SOPs and forms are to be utilized, the project management principles described in the Project Management Manual are applied using specific sponsor forms and SOPs. The project plan for each study will clearly document the SOPs and forms which are to be used on a project.
Local expertise, wherever you are
Local variations in requirements are captured in documents within the Quality Management System.
Constant oversight
Quality Management at TFS ensure the oversight of your project by risk-based internal audits, vendor audits/assessments, and reviewing quality issues in a timely manner.
Alert, adaptive, relevant
We live by our Quality Policy. This means we strive to meet or exceed all quality objectives of each project, clinical study, and investigation. We do it by maintaining expertise in GCP, GVP, and medical devices, harmonized standards, regulations and guidance, and other job skills impacting quality through ongoing training.
TFS Quality and Compliance contract-based solutions include:
Audit services:
- Vendor audits
- System audits (e.g., pharmacovigilance and statistics / data management)
- Study audits
- Investigator site audits
- Trial Master File audits
- Document audits (e.g., protocol and study report)
- Pre-inspection audits
- Risk-based audit services
- CSV audits
Quality Management System services:
- Guiding and supporting any CSV project
- Training
- Reviewing and updating QMS Documents such as Quality Manual, Policies, SOPs and WIs