Appropriate quality oversight is critical to assure patient safety and scientific integrity. CITRAS understands pharma and regulatory expectations of a robust quality management system. Recent changes such as the revised expectation on aseptic manufacturing  provided in the update to Annex 1 and the ongoing focus on data integrity require appropriate demonstration of quality controls. Whether it is support with new site setup, updates to existing quality programmes or providing assistance with quality investigations and CAPA development or training, CITRAS can help. An overview of the areas which CITRAS can support can be found below:

• QMS selection

• URS development

• Policy/Manual/SOP/WID development

• Site master file development

• Contamination control strategy development

• Validation Management

• Risk management

• Change management

• Vendor qualification management

• Root cause investigation management

• CAPA recommendations

• Training

• Inspection and audit readiness