Based on our broad experience, we assist our clients in the full range of GxP compliance issues, especially in those areas involving computerized systems.  These projects have been both short and long term and have involved many types of laboratory, manufacturing, clinical, and developmental processes and computerized systems of many platforms.  We have extensive experience in evaluating software (both in-house developed and vendor-supplied) for compliance with FDA regulations and expectations.  Many of the systems we have assessed and/or have been involved with as validation consultants have involved enterprise-wide systems spanning multiple facilities.

Our compliance consulting experience includes management consulting, audits of management practices, developmental activities for computerized systems, review of validation efforts and documentation, review and development of internal SOPs, the conduct of failure investigations, pre-submission reviews, and audits of all areas and phases of manufacturing and research and development. 

Through our management consulting efforts, we have helped our clients’ senior management to fully understand their compliance responsibilities as well as the potential magnitude of their corresponding corporate and personal exposure to regulatory enforcement.  EduQuest personnel have extensive experience in the full range of compliance and enforcement activities, including both administrative actions and criminal prosecutions. 

We also assist our clients in preparing for FDA inspections and in managing and responding to inspectional observations (Form 483 citations) and other enforcement actions, such as Warning Letters.  Our experience in both technical and compliance issues gives us the ability to objectively assess the communications problems that are often at the core of enforcement activities.  In many cases, we have been able to substantially improve our clients’ understanding of the underlying compliance issues and the clarity and effectiveness of their related communications with FDA.  We also have extensive experience in identifying, designing, coordinating, and implementing corrective actions and both the short and long term resolution of regulatory compliance problems. 

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