Quality Management

Our quality assurance team is passionate about quality assurance and improvement. With extensive experience in the quality industry Syne qua non has a proven track record of delivering a superior quality service.

The Quality Assurance team has:

Experience in all aspects of auditing systems, studies and facilities locally, nationally and internationally
Capability to design and deliver effective and innovative tailored training courses and workshops
Ability to design or review, develop and implement quality management systems
Experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), Medical Devices, ISO and UKAS standards and computer systems including FDA 21 CFR part 11 compliance.

What services Syne qua non can offer:

Audit – preparation, audit, report, follow-up and completion:

Vendor selection and oversight
Quality process and systems
Database/data management
Statistics
Clinical study report
Computer system validation
Electronic data capture (EDC) systems
Clinical laboratories
Pre-regulatory inspection

Quality Management Systems - preparation, implementation and review:

SOP writing
Document control and management
Process mapping
CAPA and trend analysis
Route cause analysis
Post regulatory inspection findings review, action planning and execution

Training – tailored to company needs:

Regulatory inspection readiness/mock inspections
Introduction to GCP and Regulatory updates
Drug Development processes
Clinical trial processes
Quality Management Systems training
Managing an Audit Programme
Induction training programmes
Serious breach
Good research practice
QA auditors training and mentoring