As a full service Contract Research Organization, Veristat’s commitment to integrity and high quality create many opportunities for company growth and repeat business. One key element in our quality management approach is our Corrective Action/Preventive Action (CAPA) Reporting system, which was implemented in August 2009. With an emphasis on compliance, CAPAs are required for all deviations, whether intentional (e.g., a deviation from standard procedures directed by a client) or unintentional, as a result of human error. We also capture client satisfaction data as well as recommendations for process improvements. For example, some process improvements are modifications to current systems or SOPs, or implementation of new processes, or enhanced training. CAPA reports may be submitted by any employee, and the system’s tracker and all CAPA reports are transparent and visible to all employees 24/7. As illustrated in this white page, CAPA is especially important in the healthcare industry. As a top-notch, competitive CRO, Veristat is keeping up with industry standards. http://www.metricstream.com/whitepapers/html/corrective_preventive_actions.htm
In our first year, we have learned that communication and resolution are the most important elements of the system. The reporting process has been augmented to ensure that all involved team members, all relevant line managers, and key senior managers are notified about the CAPA prior to its formal submission. In our experience, this notification step helps to build consensus and clarity regarding the root cause at issue. This helps pave the way for agreement on the action items recommended for resolution. Resolution is pivotal to successful implementation of process improvements.
The stated goal of Veristat’s CAPA system is to improve Veristat, a full service CRO, as a company. We always are striving to better ourselves and our CAPA system is proof of that commitment. For more information on how Veristat can assist your clinical trial needs please contact Nicole Powell at info@veristat.com