Project Based Services
Quality Assurance
Adherence to regulatory guidelines is essential to the success of your business. Early establishment of quality standards increases data confidence and mitigates regulatory obstacles as you near submission.
We provide training for your staff to perform internal audits to meet FDA and ISO requirements, and assist you in the development of appropriate auditor response techniques. BLC performs full quality documentation, processes and systems audits of your organization to assure compliance. We perform root cause analysis to solve deviations, manage unplanned events and improve efficiency. In preparation for our arrival, BLC specialists study all pertinent documentation. We perform an audit by observing the required processes with minimal invasiveness and disruption. Our promptly issued final report includes a thorough assessment, priority list, and proposed plan of implementation for your quality system master plan. If needed, we follow through on action items to support the critical resources of your quality staff.
BLC provides gap analysis, remediation plans, and assistance in monitoring the implementation of an established plan for 21 CFR part 11 compliance in the clinical research environment. We manage all levels of quality support for your organization’s needs. Furthermore, we offer training on current enforcement actions of the FDA and risk assessment for QSR audits.
We develop comprehensive Corrective Action / Preventative Action (CAPA) policies in order to meet the regulatory requirements for process improvement and design at your organization. Additionally, BLC provides turnkey CAPA solutions, based upon our evaluation of your existing status, and we will track your overall success with implementation.