Quality Systems

Syreon's Quality Assurance (QA) Department is responsible for the maintenance and documentation of its quality systems. Syreon's Quality Functions are currently divided into four major areas:

Validation of Computerized Systems

Syreon's QA Department is responsible for independent review of validation documentation and issuance of the validation certificate for each information system. In addition, QA team members are active members of Syreon's Validation Steering Committee.

Document Management

Document management functions include management of the change control process, the annual document review process and external procedural documents. QA is directly involved in the review and approval of control documents, providing writing and formatting support, distribution of change control documents and maintenance of document listings.

Regulatory Compliance

QA personnel are responsible for a wide range of regulatory compliance activities. These include regulatory review of essential documents, internal and external auditing as well as participation in audits, management of Syreon's vendor and surveillance program and regulatory consulting. In addition, QA manages nonconformance via the administration of the company's Corrective and Preventative Action (CAPA) System, which includes management of deviations, investigations and suspicion of nonconformance.

Training

Syreon's QA department is responsible for the administration of its training system which encompasses several categories of training to ensure that employees have the level of skill and knowledge necessary and required to perform their job responsibilities. These categories include:

GCP/ICH training · new employee training · job-specific training · external training · independent professional development