In a highly-regulated environment such as clinical research and drug development, knowing that your systems have the appropriate security, processes, and documentation in place in case of an audit is critical. This is true regardless of whether you are using a commercial system or one that was developed in-house. The Essex Validation and Regulatory Compliance Team utilizes a tailored, structured, and rigorous approach to systems validation that includes a set of assessment tools and checklists designed to reduce the regulatory burden while ensuring compliance. The focus of the team begins with an analysis of business needs and requirements, which are then mapped to regulatory frameworks to determine the best approach for each system or component.
Read more about the Essex Validation approach.
Read the FDA's
guidance onGeneral Principles of Software Validation