Our independent team assures Accelsiors senior management and clients of the compliance status of studies managed by Accelsiors. We provide oversight of the Quality Management System (QMS) and as part of our commitment to continual improvement, we measure, assess and report quality data while seeking ways to continually improve performance and results. Our procedures for planning, conducting and reporting audits, facilitating and follow-up of regulatory inspections and overseeing Serious Quality Issues lead to a robust corrective and preventive action (CAPA) process. This combination of processes ensures that we identify significant quality issues in time, report the findings/conclusions, document and implement corrective/preventive actions before any mistake could evolve into a regulatory risk.
We add value to your study by assisting the team in determining root causes which in turn allow the corrective and preventive actions to be put into place.
QUALITY POLICY…. QUALITY BUILT-IN
Quality is integrated into all of our clinical and business practices at Accelsiors. Our team of professionals interacts directly with Customers to understand the specific requirements for their clinical study or related service.
Accelsiors quality and regulatory affairs specialists oversee conformance with client requirements, US Food and Drug Administration (FDA) regulations, European Union directives & regulations and other applicable international agencies’ regulations.
Our experience and oversight ensures that our clinical, and related services comply with applicable Good Clinical Practices (GCP), and International Conference on Harmonization (ICH) GCP guidelines.
WE ARE CONSCIOUS OF THE IMPORTANCE OF:
- “Inspection Readiness”. Accelsiors understands that Inspection readiness is a state of mind and not a one-off preparation activity and has built a comprehensive programme to ensure the readiness of our business and studies performed by us;
- Ensuring that Quality is integrated into all of our clinical and business practices at Accelsiors. Our team of professionals interacts directly with clients to understand the specific requirements for their clinical study or related service;
- Ensuring our studies are compliant with all applicable international regulations and guidelines. Our QA team is appropriately experienced to oversee the entire Quality Management System at Accelsiors. Accelsiors has a risk-based annual audit plan in place.
KEY SERVICES PROVIDED BY ACCELSIORS QUALITY ASSURANCE TEAM:
- Independent audits of investigator sites;
- Independent audits of vendors;
- Process/system audits;
- Pre-inspection audits;
- Inspection support activities;
- Submission risk-assessments.