A Company approach
At CogState, quality is recognized as everyone's business. All internal systems are geared towards delivering a quality product and service and it is our aim to not only meet, but exceed, customer expectations.
Our Quality Management System
A quality management system based on the principles of ISO 9001:2008 governs internal processes. Standard Operating Procedures manage a range of systems including validation, project management, design and development, archiving clinical trial documentation and data, maintenance of staff training records, data handling, and quality control. All staff are trained on SOPs relevant to their job functions and notified of updates.
SOPs are reviewed at least annually and these reviews are guided by the quality management strategy group that meets regularly. Core members include the QA manager, IT manager, Operations manager and CEO.
Staff training does not stop at SOPs. Training is considered a priority at CogState and regular training sessions are held to ensure cross-area communication and knowledge sharing. Employees are actively encouraged to request additional training should they require it.
Customer focus
All aspects of the CogState service are tailored to achieve total customer satisfaction. This is achieved by: clear and documented definition of customer requirements; onsite training and training resources for study site staff; standardized instructions for subjects to ensure consistency of test administration within and across studies and ongoing technical support and regular communication.
Customer feedback is actively sought at every opportunity and is often the catalyst for updates to SOPs.
Quality control
Quality control occurs at two main junctions in a project. Before software is released to a customer, it undergoes comprehensive testing by a dedicated in-house tester. At the end of a study, the study dataset is subject to data cleaning before it is sent to the customer or to the CogState scientists for statistical analysis. During a study, all data movements and handling (e.g., test transmissions, data extractions) are automatically logged to provide a complete and detailed audit trail.
Computer Systems
A documented software development process governs development, change control and software release, a feature of which is staged sign offs (e.g., at testing completion and approval for release). Industry standard revision control systems are used to ensure an auditable trail of all changes to software.
Regulatory compliance
All systems are designed to comply with ISO 9001:2008, ICH Good Clinical Practice and FDA 21 CFR part 11 where appropriate.
Audits
CogState has been successfully audited by large pharmaceutical companies, independent software consultants and ICH GCP experts. CogState has recently been certified to ISO 9001:2008 standard.
