Auditing and Quality Assurance

Quality control steps are built into all of our processes to ensure regulatory compliance and the integrity of our clinical data. We have an independent compliance group, reporting to the CEO that conducts ongoing quality and compliance assessments of all the services we offer. We regularly conduct internal system audits to ensure compliance with GXPs, SOPs, vendor qualifications and commitments to our clients. The internal audit program is an integral part of Prologue’s continuous improvement program.

Prologue’s compliance group includes certified quality auditors with extensive experience and training in GCPs, GLPs, 21 CFR Part 11, computer system validation and audit techniques.

Audit activities include:

• Clinical site audits
• Vendor audits
• Validation/Part 11 compliance audits
• Internal system/process audits
• Audits of databases, statistical tables, and clinical study reports

Prologue’s quality control, quality assurance and auditing activities assure we deliver the highest quality services and products to our clients.